← Product Code [LZS](/productcode/LZS) · P930016S025

# STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM (P930016S025)

_Amo Manufacturing USA, LLC · LZS · Jul 11, 2007 · Ophthalmic · APPR_

**Canonical URL:** https://fda-staging.innolitics.com/device/P930016S025

## Device Facts

- **Applicant:** Amo Manufacturing USA, LLC
- **Product Code:** [LZS](/productcode/LZS.md)
- **Decision Date:** Jul 11, 2007
- **Decision:** APPR
- **Device Class:** Class 3
- **Review Panel:** Ophthalmic
- **Attributes:** Therapeutic

## Indications for Use

The STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and the WaveScan® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: - 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision, - with myopic astigmatism up to -6.00 D MRSE, with cylinder up to -3.00 D, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia, - with documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and - with a successful preoperative trial of monovision or history of monovision experience.

## Device Story

System uses WaveScan WaveFront® diagnostic instrument to measure refractive errors and higher-order aberrations via Hartmann-Shack sensor; data processed via Fourier Transform analysis to generate custom ablation targets. STAR S4 IR™ Excimer Laser (193 nm) delivers variable spot scanning (VSS™) ultraviolet pulses to cornea. ActiveTrak™ infrared eye tracking and iris registration (IR™) align laser to eye; ozone compensation system controls beam energy. Procedure performed by ophthalmologist in clinic. WaveScan-derived instructions transferred to laser via encrypted USB/floppy. Output is corneal reshaping to achieve monovision (targeted myopia in non-dominant eye). Benefits include increased spectacle independence for presbyopic patients. Clinical decision-making supported by preoperative monovision trial and wavefront analysis.

## Clinical Evidence

Prospective, multi-center, open-label, non-randomized study (IDE G040024) of 160 subjects (40-65 years old). Primary endpoints at 6 months: UCVA, MRSE predictability, refractive stability, satisfaction, spectacle dependence. Results: 86.7% of subjects achieved binocular UCDVA 20/20 or better; 88% achieved binocular UCNVA 20/20 or better. Stability achieved at 6 months. Adverse events included DLK (12 cases), corneal infiltrate (1), and elevated IOP (2). No deaths reported.

## Technological Characteristics

193 nm excimer laser; variable spot scanning (VSS™) delivery (0.65-6 mm diameters). Hartmann-Shack wavefront sensor; CCD imaging. Iris registration (IR™) system. Ozone compensation system. ActiveTrak™ infrared eye tracking. Connectivity via encrypted data transfer (USB/floppy). Software: WaveScan v3.8, STAR v5.21. Class III accessory (WaveScan).

## Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA

# FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

# I. GENERAL INFORMATION

|  Device Generic Name: | Ophthalmic Excimer Laser System  |
| --- | --- |
|  Device Trade Name: | VISX STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System  |
|  Applicant's Name and Address: | VISX, Incorporated 3400 Central Expressway Santa Clara, CA 95051-0703  |
|  Date of Panel Recommendation: | None  |
|  Premarket Approval (PMA) Application Number: | P930016/S025  |
|  Date of Notice of Approval to Applicant: | July 11, 2007  |

The STAR Excimer Laser was originally approved on March 27, 1996, under PMA P930016, for the limited indication for myopic photorefractive keratectomy (PRK) using a 6.0 mm ablation zone in patients 18 years of age or older with 1.0 to 6.0 diopters (D) of myopia with astigmatism of ≤ 1.0 D whose refractive change for one year prior to treatment is within ± 0.5 D.

This clinical indication was expanded in supplements 3 (approved on April 24, 1997), 5 (approved on January 29, 1998), 7 (approved November 2, 1998), and 10 (approved October 18, 2000) to include PRK in patients 21 years of age or older in PRK treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12.0 D spherical myopia at the spectacle plane and up to -4.0 D of astigmatism, hyperopia (sphere only) of between +1.0 and +6.0 D spherical equivalent with no more than 1.0 D of refractive astigmatism, and hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with refractive astigmatism from +0.5 to +4.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D. On November 19, 1999 (P990010), the clinical indication was further expanded to include laser in situ keratomileusis (LASIK) treatments in patients 18 years of age or older for the reduction or elimination of myopia (nearsightedness) from 0 to -14.0 D with or without -0.50 to -5.0 D of astigmatism. Supplement 12 (approved April 27, 2001) expanded the indication to include patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 D and +5.0 D sphere at the spectacle plane with or without refractive astigmatism up to +3.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D. Supplement 14 (approved November 16, 2001) expanded the indication for the reduction or elimination of naturally occurring mixed astigmatism where the magnitude of cylinder (≤ 6.0 D at the spectacle plane) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs. Supplement 15 (approved August 7, 2002) added an auto-centering function to the ActiveTrak™ eye tracking system and changed the trade name to the STAR S4. Supplement 16 (approved May 23, 2003) expanded the clinical indication for

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wavefront-guided LASIK for the reduction or elimination of myopic astigmatism up to - 6.00 D MRSE, with cylinder between 0.00 and -3.00 D. Supplement 18 (approved June 7, 2004) introduced the Fourier Transform Analysis of Hartmann-Shack data in WaveScan Version 3.50. Supplement 17 (approved December 14, 2004) expanded the clinical indication for wavefront-guided LASIK for the reduction or elimination of hyperopic astigmatism up to 3.00 D MRSE, with cylinder between 0.00 and 2.00 D. Supplement 19 (approved February 18, 2005) added an iris registration system, an ozone compensation system, and changed the trade name to the STAR S4 IR™ Excimer Laser System. Supplement 20 (approved March 17, 2005) expanded the clinical indication for wavefront-guided LASIK for the reduction or elimination of naturally occurring mixed astigmatism when the magnitude of cylinder (from 1.0 to 5.0 D) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs. Supplement 22 (approved May 2, 2005) included refinements to the iris registration system. Supplement 21 (approved August 3, 2005) expanded the clinical indication for wavefront-guided LASIK to include the reduction or elimination of high myopic astigmatism up to -11.00 D MRSE with cylinder up to -3.00 D. Supplement 23 (approved September 28, 2005) implemented an algorithm adjustment for wavefront-guided LASIK treatments of high myopic astigmatism. Supplement 24 (approved May 3, 2006) introduced WaveScan software user interface changes.

The sponsor submitted this supplement to further expand the wavefront-guided LASIK clinical indications to include the visual correction of presbyopic patients with monovision, achieved by the targeted retention of -1.25 D to -2.0 D of myopia in the non-dominant eye of presbyopic myopes with low to moderate myopic astigmatism (up to -6.00 D MRSE with cylinder up to -3.00 D). The updated clinical data to support the expanded indication is provided in this summary. For more information on the data which supported the approved indications, the summaries of safety and effectiveness data (SSED) for P930016 and P990010 should be referenced. Written requests for copies of the SSED can be obtained from the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857 under Docket # 97M-0084 (P930016 and S3), Docket # 99M-0293 (S5), Docket # 00M-1391 (S7), Docket # 01M-0015 (S10), Docket # 01M-0305 (S12), Docket # 01M-0522 (S14), Docket # 03M-0333 (S16), Docket # 05M-0055 (S17), Docket # 05M-0151 (S20), Docket # 05M-0382 (S21), and Docket # 00M-1447 (P990010) or you may download the files from the internet sites http://www.fda.gov/cdrh/pdf/p930016.pdf and http://www.fda.gov/cdrh/pdf/p990010.pdf.

# II. INDICATIONS FOR USE

The STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and the WaveScan® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes:

- 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision,
- with myopic astigmatism up to -6.00 D MRSE, with cylinder up to -3.00 D, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia,
- with documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and
- with a successful preoperative trial of monovision or history of monovision experience.

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# III. CONTRAINDICATIONS

Laser refractive surgery is contraindicated:

- in patients with collagen vascular, autoimmune or immunodeficiency diseases.
- in pregnant or nursing women.
- in patients with signs of keratoconus or abnormal corneal topography
- in patients who are taking one or both of the following medications: isotretinoin (Accutane®) or amiodarone hydrochloride (Cordarone®).

# IV. WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the device labeling.

# V. DEVICE DESCRIPTION

A. WaveScan WaveFront® System

The WaveScan WaveFront System is an integral part of this approval. It is a class III accessory device and has a separate user manual. It is a diagnostic instrument indicated for the automated measurement, analysis, and recording of refractive errors of the eye: including myopia, hyperopia, astigmatism, coma, spherical aberration, trefoil, and other higher order aberrations through sixth order, and for displaying refractive data of the eye to assist in prescribing refractive correction.

The WaveScan WaveFront System measures the refractive error and wavefront aberrations of the human eye using a Hartmann-Shack wavefront sensor. The measurements can be used to determine regular (sphero-cylindrical) refractive errors and irregularities (aberrations) that cause decreased or blurry vision in the human eye.

The function of the Hartmann-Shack sensor is to measure the refractive error of the eye by evaluating the deflection of rays emanating from a small beam of light projected onto the retina. To control the natural accommodation of the eye during WaveScan® system imaging, the system incorporates a fogged fixation target.

The WaveScan System optical head projects a beam of light onto the retina. The light reflects back through the optical path of the eye and into the wavefront device. The reflected beam is imaged by a lenslet array onto the charge-coupled device (CCD). Each lens of the array gathers light information (deflection information) from a different region of the pupil to form an image of the light that passes through that region of the pupil. An array of spots is imaged on the CCD sensor. The system compares the locations of the array of spots gathered from the CCD to the theoretical ideal (the ideal plane wave).

The WaveScan System software uses these data to compute the eye's refractive errors and wavefront aberrations using Fourier Transform analysis. The system displays the refractive errors and wavefront aberrations as the optical path difference (OPD) between the measured outgoing wavefront and the ideal plane wave. The WaveScan system software subtracts the

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refractive errors from the wavefront errors map and displays the higher order aberrations as OPD errors. Regions of the pupil with positive OPD are in front of the ideal plane wave and areas with negative OPD are behind the ideal plane wave.

# 1. Data Collection

The eye of the patient is centered in the instruments field of view and the image of the eye is brought in focus. As the patient fixates on the target, the fogging system is engaged to optically adjust the position of the target beyond the far point of the patient. This forces the patient to relax their accommodative system, so that the refraction of the eye is measured accurately. There is no pharmaceutical eye dilation required for the patient.

# 2. Wavefront Measurement

During the data capture, four images are captured from the Hartmann-Shack camera within a short interval of time. The pupil camera of the instrument captures the image of the eye during the same time interval. The spot pattern images are processed to reconstruct the wavefront and if two or more of them pass the acceptance criteria, the valid measurements are averaged to yield the final measurement for the examination.

# 3. Registration

Internal instrument calibration establishes the coordinate transformation between the pupil imaging camera and the Hartmann-Shack camera, so that the wavefront map can be correctly centered at the center of the pupil during the measurement.

# 4. Treatment Design

The target treatment shape is automatically calculated by the WaveScan instrument from the wavefront data. Once the target shape is established, VSS™ software module generates the commands for the laser to create the target shape on the cornea. Corneal geometry, represented by the keratometry values, is taken into account in computing the laser instructions. CustomVue™ ablations to achieve monovision by the targeted retention of between approximately -1.25 to -2.00 D myopia in the non-dominant eye of presbyopic patients with low to moderate myopia and myopic astigmatism are approved for an optical zone of 6.0 mm, and an ablation zone of 8.0 mm. No treatments with optical zones greater than 6.0 mm were attempted in the U.S. Clinical Trial. All treatments utilized a variable repetition rate to a maximum of 20 Hz.

# 5. New Software Features

The final commercial release versions for CustomVue™ Monovision LASIK are WaveScan software version 3.8 together with STAR software version 5.21. The WaveScan software is capable of calculating treatments with an optical zone up to 9.0 mm with total ablation zone up to 9.5 mm. WaveScan® System Software 3.8 is designed to allow the targeted retention of up to -2.00 (D) diopters of myopia in the non-dominant

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eye of presbyopic patients with myopia. The upper limit of the Physician Adjustment of Sphere is increased to +2.75 (D) diopters. WaveScan® System Software 3.8 also contains a Chromatic Aberration Adjustment which compensates for differences in measured refractive values between the WaveScan® System and manifest refractions due to chromatic aberration that consists of a -0.50 D spherical offset. The effect of this adjustment will ensure that WaveScan® System-derived refractions will more closely match the measured manifest refractions, when compared at optical infinity. This adjustment affects the displayed refraction and intended ablation target derived from all WaveScan® System measurements. An additional feature of WaveScan® System Software 3.8 is a treatment algorithm adjustment to ensure that the chromatic aberration adjustment does not compromise the accuracy of intended outcomes after CustomVue™ treatments. Compensatory algorithm adjustments have been made in WaveScan® System upgrade to Software 3.8. The algorithm adjustment for high myopia introduced in WaveScan® System Software 3.65 has been removed, and a new algorithm adjustment consisting of a 0.25 D spherical offset and 8% boost in ablation efficiency is applied consistently to all treatments. After the WaveScan® System upgrade to Software 3.8, exams measured with previous versions of software will not be eligible for treatment planning.

# 6. Data Transfer

The treatment files produced by the WaveScan® instrument contain information about the patient, such as name, ID and refractive data and the set of instructions for the VISX STAR laser system. They are copied onto a USB flash drive or floppy disk for transfer to the laser. The files are encrypted to prevent data tampering or data corruption.

7. Features and components of the WaveScan WaveFront® System include:

- Computer Control
- PC and Monitor
- Isolation Transformer
- Power Supply
- LED
- Optical Head
- Printer
- Motorized table

# B. Microkeratome

The LASIK procedure required the use of a commercially available keratome that has been cleared for marketing via premarket notification. Three different keratomes were used in this study. Two devices consisted of a sterilization/storage tray which includes the shaper head, a left/right eye adapter, suction ring, suction handle, blade handling pin, and corneal reference marker. The instrument motor, tonometer, cleaning brush, disposable blades, power/suction supply unit with vacuum and motor footswitches and power cords are provided as separate components in an accessory stand and equipment suitcase which complete the system. The third device was a femtosecond ophthalmic surgical laser that creates a LASIK flap through precise

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individual microphotodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

# C. STAR S4 IR™ Excimer Laser System

The STAR S4 IR laser system is a 193 nm excimer laser system that delivers spatially scanning ultraviolet pulses of variable diameters and slits on to the cornea. The range of diameters and slits available during treatments are 0.65 mm to 6 mm. An auto-centering dual camera infrared eye tracking system (ActiveTrak™), together with the delivery system, aligns the treatment to the eye, and compensates for eye movements during laser correction to maximize the corneal reshaping accuracy. An operating microscope is used to observe the patient procedures and to facilitate accurate focus and laser beam alignment. A debris-removal system is designed to evacuate the debris plume that occurs during ablation. The operating chair and fixation LED align the patient, while a video camera and monitor records the patient treatment.

The variable spot scanning (VSS™) feature of the laser, used for CustomVue™ treatments delivers variable diameter ultraviolet pulses to precise locations by the scanning delivery system. The VSS algorithm optimizes the ablation pattern by choosing the best combination of beam diameters and locations to achieve a target shape. VSS expands the laser capability to achieve a broader spectrum of ablation shapes than conventional treatments because the conventional algorithm optimizes only the diameter for myopic treatments and slits for hyperopic treatments.

Conventional STAR treatments utilize sphere, cylinder and axis components which are entered manually into the laser by the operator to generate the ablation treatment. CustomVue™ treatment information is generated on the WaveScan® system and transferred to the STAR S4 IR™ Excimer Laser System. The transferred information includes patient information, eye and refraction information, image of the eye, eye alignment information, and ablation instructions to the laser for beam diameters and the exact locations of the beam on the cornea. The VISX® Treatment card defines the number and the types of treatments available.

Wavefront-guided treatments using the STAR S4 IR™ and WaveScan Systems utilize an automated iris registration (IR™) system. The angle of rotation of the patient's eye under the laser is determined by comparing features of the iris on the WaveScan image to the same features located in the image of the iris taken using the STAR S4 IR™ camera. The treatment is rotated to align precisely with the rotation of the patient's eye under the laser. In supplement 19, VISX received approval allowing the iris registration (IR) modification to be used with all existing approved indications. Minor software improvements to the IR subsystem were also approved in supplement 22.

The STAR S4 IR laser software also contains a refinement to the method of STAR laser beam energy control by inclusion of an ozone compensation system.

Features and components of the STAR S4 IR System include:

- Excimer Laser
- Gas Management System
- Laser Beam Delivery System
- Patient Management System
- Computer Control
- VISX Treatment Card

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# VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are currently several other alternatives for visual correction in presbyopic patients with myopic astigmatism:

- Bifocal, trifocal or progressive lens spectacles.
- Contact lenses, either monofocal, multifocal, or monovision.
- Other laser refractive surgery (wavefront-guided LASIK, conventional LASIK, or PRK) to correct distance vision, with reading glasses used for near vision.
- Other non-laser refractive surgery such as Radial Keratotomy (RK) or Automated lamellar keratoplasty (ALK) to correct distance vision, with reading glasses used for near vision.

Each alternative has its own advantages and disadvantages. A prospective patient should fully discuss with his/her care provider these alternatives in order to select the correction method that best meets his/her expectation and lifestyle.

# VII. MARKETING HISTORY

The WaveScan WaveFront® System has been distributed in approximately 48 countries (Argentina, Aruba, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Malaysia, Mexico, The Netherlands, Philippines, Russia, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Thailand, Trinidad & Tobago, Turkey, UAE, United Kingdom, the United States, Uruguay and Vietnam). The WaveScan WaveFront System has not been withdrawn from any country or market for reasons of safety or effectiveness.

# VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

Potential adverse reactions associated with LASIK include: loss of best spectacle corrected visual acuity (BSCVA), worsening of patient complaints such as double vision, sensitivity to bright lights, increased difficulty with night vision, fluctuations in vision, increase in intraocular pressure, corneal haze, secondary surgical intervention, corneal infiltrate or ulcer, corneal epithelial defect, corneal edema, problems associated with the flap including a lost, misplaced or misaligned flap, retinal detachment, and retinal vascular accidents.

Please refer to the complete listing of adverse events and complications observed during the clinical study which are presented in tables 31 and 32 of the Summary of Clinical Studies section.

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# IX. SUMMARY OF PRECLINICAL STUDIES

A. STAR Excimer Laser System

For a summary of non-clinical studies (excluding hazard analysis and software testing) for the STAR Excimer Laser System, refer to the SSED of the original PMA #P930016.

B. WaveScan Wavefront® System

1. Hazard Analysis

Hazard Analysis and Software Testing was conducted for the combined use of the WaveScan WaveFront System and the STAR Excimer Laser System.

2. Testing for Measurement of Refractive Errors of the Eye with WaveScan Wavefront System

A bench top study for the measurement of total refractive errors of the eye, including myopia, astigmatism, coma, spherical aberrations, trefoil and other higher order aberrations through sixth order, and Software Testing was conducted for the WaveScan WaveFront® System. The test was designed to measure conventional aberrations in a VISX model eye and in 8 phase plates with different combinations of Zernike aberrations. The data from this study indicated the VISX WaveScan WaveFront System provides an adequate and reliable measurement of total refractive errors of the eye, including myopia, astigmatism, coma, spherical aberration, trefoil and other higher order aberration through sixth order.

3. Profilometry of Ablation

As a part of this PMA, VISX validated the accuracy of spherical adjustment of the WaveScan-derived ablation target by performing test ablations on plastic surfaces, with and without a spherical adjustment. Ablations were scanned with a surface profilometer and showed very good agreement to theoretical targets.

# X. SUMMARY OF CLINICAL STUDIES

A clinical study of LASIK treatment, with the VISX STAR S4 IR® Excimer Laser System with Variable Spot Scanning and WaveScan® System-derived ablation targets to achieve monovision for the correction of presbyopic patients with low to moderate myopia with or without astigmatism, was conducted under IDE G040024. The data from this study are presented as a basis for consideration and approval. Specifically, safety and effectiveness outcomes at 6 months postoperatively were assessed, as stability was reached by that time. The IDE study is described in detail as follows:

A. Study Objective

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The objective of this clinical investigation was to demonstrate that monovision LASIK treatment with the VISX STAR Excimer Laser System with Variable Spot Scanning and WaveScan derived ablation targets is safe and effective for the visual correction of presbyopic patients with myopia with and without astigmatism.

### B. Study Design

This was a prospective, multi-center, open-label, non-randomized study where the primary control was the preoperative state of the treated eye (i.e., comparison of pretreatment and post-treatment visual parameters in the same eye).

### C. Inclusion and Exclusion Criteria

Enrollment in the study on the effect of LASIK treatment with the VISX STAR Excimer Laser System using Variable Spot Scanning technology with WaveScan® System-derived ablation targets was limited to those subjects who met the following inclusion criteria in their operative eye(s):

- Male or female, of any race, and at least 40 years old at the time of the pre-operative examination.
- Dominant eye with manifest refraction spherical equivalent up to -6.0 D, with astigmatism up to -3.0 D at the spectacle plane.
- Non-dominant eye with MRSE up to -6.0 D, with astigmatism up to -3.0 D at the spectacle plane, and minimum pre-operative myopia at least as great as the targeted post-operative myopia, with a planned laser treatment (based on the WaveScan measurement) of at least 0.75 diopter sphere or spherical equivalent, or no required treatment to achieve the intended outcome.
- Best spectacle corrected visual acuity (BSCVA) of 20/20 or better.
- Wavefront measurement diameter ≥ 5.0 mm.
- Manifest refraction within ± 0.50 D of WaveScan refraction (sphere and cylinder) and no more than 15 degrees of difference between axes for eyes with cylinder greater than 0.50 D.
- Manifest refraction within ± 0.50 D of Cycloplegic refraction (sphere).
- WaveScan refraction within ± 0.50 D of Cycloplegic refraction (sphere and cylinder) and no more than 15 degrees of difference between axes for eyes with cylinder greater than 0.50 D.
- Pachymetric measurement minus the maximal depth ablated (as described by the VISX software) added to the flap thickness is greater than or equal to 250 microns (i.e., Pachymetry — [Depth of ablation + Flap thickness] ≥ 250 microns).
- Eyes that demonstrated refractive stability confirmed by a change of less than or equal to 0.50 diopter (sphere and cylinder) at an exam at least 12 months prior to the baseline examination. The astigmatic axis must also be within 15 degrees for eyes with cylinder greater than 0.50 D.
- Contact lens wearers who removed soft lenses at least 1 week prior and rigid (Gas permeable and PMMA) lenses at least 2 weeks prior to baseline measurements. At that baseline examination, cycloplegic and manifest refractions as well as corneal topography were obtained. If the investigator determined that the topography was

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within normal limits, surgery was scheduled at least one week after the initial exam, with no contact lens wear permitted prior to the surgery. If on the day of scheduled surgery, for the operative eye, repeat central keratometry readings and manifest refraction spherical equivalents did not differ significantly from the initial exam measurements (by more than 0.50 diopter), surgery proceeded. If the refractive change exceeded this criterion, the surgery was rescheduled after refractive stability was achieved.

- Planned treatment such that the anticipated post-operative keratometry value in any meridian will be \(>33\) D. Anticipated post-operative keratometry values will be calculated by multiplying the MRSE by 0.8, and subtracting that value from the mean pre-operative keratometry value. In other words, \(\left[\left(\text{Flat K} + \text{Steep K}\right) \times 0.5\right] - (\text{MRSE} \times 0.8)\) \(>33\) D.
- Subjects willing and capable of returning for follow-up examinations for the duration of the study.

Subjects were not permitted to enroll in the study if they met any of the following exclusion criteria:

Female subjects who were pregnant, breast-feeding or intended to become pregnant over the course of the study.
- Subjects whose fellow eye did not meet all inclusion criteria or fall within approved indications for treatment using the VISX STAR Excimer Laser.
- Subjects who used concurrent topical or systemic medications which might have impaired healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment.

NOTE: The use of topical or systemic corticosteroids, whether chronic or acute, was deemed to adversely affect healing and subjects using such medication were specifically excluded from eligibility.

- Subjects who had a history of any of the following medical conditions, or any other condition that could have affected wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.

NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, specifically excluded subjects from eligibility.

- Subjects who had a history of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring), at risk for developing strabismus, evidence of glaucoma, or propensity for narrow angle glaucoma in the operative eye(s).

NOTE: This included any subject with open angle glaucoma, regardless of medication regimen or control. Additionally, any subject with an intraocular pressure (IOP) greater than 21 mm Hg at baseline was specifically excluded from eligibility.

- Subjects who had evidence of keratoconus, corneal irregularity, or abnormal videokeratography in the operative eye(s).

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- Subjects who had known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Subjects who were participating in any other clinical trial.

D. Study Plan, Subject Assessments, and Efficacy Criteria

All subjects were expected to return for follow-up examinations at 1 and 7 days, and 1, 3, 6, 9, 12 and 24 months postoperatively.

Subjects were permitted to have second eyes (fellow eyes) treated at the discretion of the investigator at the same time as the first eye (primary eyes) or after the primary eye treatment.

In addition, subjects were eligible for retreatment no sooner than 3 months after treatment with submission of appropriate clinical data, planned treatment, and agreement of the medical monitor in advance.

All study treatments were conducted using a 6 mm optical zone and an 8 mm ablation zone with intention of full correction to emmetropia. The parameters measured during the study were:

- At 24 hours and 1 week: subjective patient symptoms, UCVA, and anterior segment examination by biomicroscopy. Manifest refraction and BSCVA were also conducted on each subject at the 1-week visit. Adverse events, complications, medications and other clinical findings were also noted.
- At 1 and 3 months: visual acuity (uncorrected, and best spectacle corrected), manifest refraction, keratometry, videokeratography, WaveScan® measurement, contrast sensitivity, reading function, applanation tonometry, anterior segment examination by biomicroscopy, and a subjective questionnaire. Dim pupil size was also conducted on each subject at the 3-month visit only. Adverse events, complications, medications and other clinical findings were also noted.
- At 6, 9, 12, and 24 months: visual acuity (uncorrected and best spectacle corrected), manifest refraction, keratometry, corneal videokeratography, WaveScan measurement, contrast sensitivity, reading function, applanation tonometry, anterior segment examination by biomicroscopy, and a subjective questionnaire. After cycloplegia, a refraction, dilated media and fundoscopic examination were performed. Adverse events, complications, medications, and other clinical findings were noted as appropriate. Stereopsis was also conducted on each subject at the 6-month visit only. During the 9 month post-operative examination, contrast sensitivity, the subjective questionnaire, cycloplegia and post-cycloplegia testing were not required. An assessment of distance glasses was conducted at 9 and 12-months only.

The primary efficacy variables for this study were: improvement of UCVA, predictability of manifest refraction spherical equivalent (MRSE), refractive stability, subject satisfaction, and assessment of spectacle dependence.

E. Study Period and Investigational Sites and Demographics

1. Study Period and Investigational Sites

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
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One hundred and sixty subjects were treated in this study at seven U.S. centers between September 28, 2004 and September 30, 2005. There were 7 investigational sites that provided eligible data for analysis.

# 2. Demographics

Of the 160 treated subjects, 35.0% (56/160) were from male subjects and 65.0% (104/160) were from female subjects. Furthermore, 81.9% (131/160) were Caucasians, 5.0% (8/160) were African Americans, 4.4% (7/160) were Asian/Pacific Islanders, and 7.5% (12/160) were of other races, reported as Hispanic. The left eye was dominant in 28.8% (46/160) of the cases and the right eye was dominant in 71.3% (114/160) of the cases. The age of the subjects ranged from 40 to 65 years, with a mean of 50.2 years.

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
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Table 1 presents demographic information for all subjects.

|  Table 1: Demographic Characteristics All Subjects (N=160)  |   |   |   |
| --- | --- | --- | --- |
|  Category | Classification | n | %  |
|  Gender | Male | 56 | 35.0  |
|   | Female | 104 | 65.0  |
|  Race | Caucasian | 131 | 81.9  |
|   | African American | 8 | 5.0  |
|   | Native American/ Alaskan Native | 2 | 1.3  |
|   | Asian | 7 | 4.4  |
|   | Other* | 12 | 7.5  |
|  Dominant Eyes | Right | 114 | 71.3  |
|   | Left | 46 | 28.8  |
|  Contact Lens History** | None | 35 | 21.9  |
|   | Soft | 115 | 71.9  |
|   | RGP/PMMA | 10 | 6.3  |
|  Monovision History | Prior Monovision Contact Lens Use | 67 | 41.9  |
|   | No Prior Monovision Contact Lens Use | 93 | 58.1  |
|  Age (in Years) | Mean | 50.2  |   |
|   | SD | ±5.1  |   |
|   | Min | 40  |   |
|   | Max | 65  |   |

*Other classification of "race" included: Hispanic

**Contact Lens History was not available for three subjects. The percentage for this portion of the analysis is based on non-missing values.

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
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# F. Data Analysis and Results

# 1. Preoperative Characteristics

Tables 2 and 3 contain a summary of the preoperative manifest refractive error stratified by manifest refraction spherical equivalent and cylinder, expressed in minus cylinder notation, for treated dominant and non-dominant eyes, respectively. All refractions were measured at 4 meters and adjusted to a standard vertex distance (12.5 mm) and optical infinity (by subtracting 0.25 D from the spherical component of the refraction) for data analysis and presentation.

|  Table 2: Pre-Op Refractive Error Stratified by Manifest Spherical Equivalent and Cylinder Dominant Eyes (N=159)  |   |   |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | Cylinder (in minus notation)  |   |   |   |   |   |   |   |   |   |   |   |
|   | 0 to -0.5 D |   | <-0.5 to -1 D |   | <-1 to -2 D |   | <-2 to -3 D |   | <-3 to -4 D |   | Total  |   |
|  MRSE | n | % | n | % | n | % | n | % | n | % | n | %  |
|  <0 to -1 D | 1 | 0.6 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 0.6  |
|  <-1 to -2 D | 10 | 6.3 | 1 | 0.6 | 1 | 0.6 | 0 | 0.0 | 0 | 0.0 | 12 | 7.5  |
|  <-2 to -3 D | 19 | 11.9 | 8 | 5.0 | 7 | 4.4 | 0 | 0.0 | 0 | 0.0 | 34 | 21.4  |
|  <-3 to -4 D | 25 | 15.7 | 10 | 6.3 | 5 | 3.1 | 0 | 0.0 | 0 | 0.0 | 40 | 25.2  |
|  <-4 to -5 D | 17 | 10.7 | 18 | 11.3 | 8 | 5.0 | 0 | 0.0 | 1 | 0.6 | 44 | 27.7  |
|  <-5 to -6 D | 12 | 7.5 | 7 | 4.4 | 5 | 3.1 | 0 | 0.0 | 0 | 0.0 | 24 | 15.1  |
|  <-6 D | 2 | 1.3 | 2 | 1.3 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 4 | 2.5  |
|  Total | 86 | 54.1 | 46 | 28.9 | 26 | 16.4 | 0 | 0.0 | 1 | 0.6 | 159 | 100  |

|  Table 3: Pre-Op Refractive Error Stratified by Manifest Spherical Equivalent and Cylinder Non-Dominant Eyes (N=137)  |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | Cylinder (in minus notation)  |   |   |   |   |   |   |   |   |   |
|   | 0 to -0.5 D |   | <-0.5 to -1 D |   | <-1 to -2 D |   | <-2 to -3 D |   | Total  |   |
|  MRSE | n | % | n | % | n | % | n | % | n | %  |
|  <0 to -1 D | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0  |
|  <-1 to -2 D | 0 | 0.0 | 0 | 0.0 | 1 | 0.7 | 0 | 0.0 | 1 | 0.7  |
|  <-2 to -3 D | 18 | 13.1 | 2 | 1.5 | 5 | 3.6 | 0 | 0.0 | 25 | 18.2  |
|  <-3 to -4 D | 26 | 19.0 | 8 | 5.8 | 7 | 5.1 | 0 | 0.0 | 41 | 29.9  |
|  <-4 to -5 D | 22 | 16.1 | 8 | 5.8 | 6 | 4.4 | 2 | 1.5 | 38 | 27.7  |
|  <-5 to -6 D | 15 | 10.9 | 7 | 5.1 | 6 | 4.4 | 1 | 0.7 | 29 | 21.2  |
|  <-6 D | 2 | 1.5 | 0 | 0.0 | 1 | 0.7 | 0 | 0.0 | 3 | 2.2  |
|  Total | 83 | 60.6 | 25 | 18.2 | 26 | 19.0 | 3 | 2.2 | 137 | 100  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
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# 2. Postoperative Results

a. Subject Accountability

Of the 292 eyes treated, over 97% accountability was achieved at all postoperative visits. Table 4 presents subject accountability over time.

|  Table 4: Subject Accountability  |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | 1 Month |   | 3 Months |   | 6 Months |   | 9 Months |   | 12 Months  |   |
|   | n | % | n | % | n | % | n | % | n | %  |
|  Dominant Eyes (N=159)  |   |   |   |   |   |   |   |   |   |   |
|  Available for Analysis | 158 | 99.4 | 156 | 98.1 | 157 | 98.7 | 151 | 95.0 | 148 | 93.1  |
|  Discontinued† | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 4 | 2.5 | 7 | 4.4  |
|  Missed Visit | 1 | 0.6 | 2 | 1.3 | 1 | 0.6 | 3 | 1.9 | 3 | 1.9  |
|  Not yet eligible | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0  |
|  Lost to Follow-Up | 0 | 0.0 | 1 | 0.6 | 1 | 0.6 | 1 | 0.6 | 1 | 0.6  |
|  % Accountability* | 99.4% |   | 98.1% |   | 98.7% |   | 97.4% |   | 98.2%  |   |
|  Non-Dominant Eyes (N=137)  |   |   |   |   |   |   |   |   |   |   |
|  Available for Analysis | 136 | 99.3 | 134 | 97.8 | 135 | 98.5 | 133 | 97.1 | 133 | 97.1  |
|  Discontinued† | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 0.7 | 1 | 0.7  |
|  Missed Visit | 1 | 0.7 | 2 | 1.5 | 1 | 0.7 | 2 | 1.5 | 2 | 1.5  |
|  Not yet eligible | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0  |
|  Lost to Follow-Up | 0 | 0.0 | 1 | 0.7 | 1 | 0.7 | 1 | 0.7 | 1 | 0.7  |
|  % Accountability* | 99.3% |   | 97.8% |   | 98.5% |   | 97.8% |   | 99.0%  |   |
|  Subjects (N=160)  |   |   |   |   |   |   |   |   |   |   |
|  Available for Analysis | 159 | 99.4 | 157 | 98.1 | 158 | 98.8 | 152 | 95.0 | 149 | 93.1  |
|  Discontinued† | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | 4 | 2.5% | 7 | 4.4%  |
|  Missed Visit | 1 | 0.6% | 2 | 1.3% | 1 | 0.6% | 3 | 1.9% | 3 | 1.9%  |
|  Not yet eligible | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | 0 | 0.0% | 0 | 0.0%  |
|  Lost to Follow-Up | 0 | 0.0% | 1 | 0.6% | 1 | 0.6% | 1 | 0.6% | 1 | 0.6%  |
|  % Accountability* | 99.4% |   | 98.1% |   | 98.8% |   | 97.4% |   | 97.4%  |   |

*%Accountability= [Available for Analysis/(enrolled-discontinued-not yet eligible)] x100

†5 eyes of 4 subjects underwent retreatment after the 6-month visit, and 3 eyes of 3 subjects underwent retreatment after the 9-month visit.

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
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# b. Stability of Outcome

Stability of outcome was evaluated for dominant eyes with refractions at two consecutive visits. Between all consecutive visits, 100% of dominant eyes experienced a change of 1.0 diopter or less. Between the 3 and 6-month visits, the mean change in MRSE for dominant eyes was -0.03 D. This represents an annualized change in MRSE of -0.12 D. Stability was achieved at 6 months, and maintained through 12 months. The confidence intervals for the mean change in MRSE include zero between the 3 and 6, 6 and 9, and 9 and 12-month visits. Table 5 presents refractive stability data for dominant eyes with two consecutive visits.

|  Table 5: Stability of MRSE: Two Consecutive Visits Dominant Eyes (N=159)  |   |   |   |   |
| --- | --- | --- | --- | --- |
|   | Between 1 and 3 Months | Between 3 and 6 Months | Between 6 and 9 Months | Between 9 and 12 Months  |
|   | (n=155) | (n=155) | (n=150) | (n=145)  |
|  Change in MRSE by ≤ 0.5 D 95% CI | 148 95.5% (90.9, 98.2) | 150 96.8% (92.6, 98.9) | 150 100% (98.0, 100) | 144 99.3% (96.2, 100)  |
|  Change in MRSE by ≤ 1.0 D 95% CI | 155 100% (98.1, 100) | 155 100% (98.1, 100) | 150 100% (98.0, 100) | 145 100% (98.0, 100)  |
|  Mean Change in MRSE ± SD 95% CI | -0.08 ± 0.25 (-0.12, -0.04) | -0.03 ± 0.23 (-0.07, 0.00) | -0.02 ± 0.18 (-0.05, 0.01) | 0.00 ± 0.18 (-0.03, 0.03)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

At least 99% of non-dominant eyes experienced a change of 1.0 diopter or less over all consecutive visits. Between the 3 and 6-month visits, the mean change in MRSE for non-dominant eyes was -0.03 D, representing an annualized change in MRSE of -0.12 D. Stability of MRSE for non-dominant eyes was achieved at 6 months and maintained through 12 months. The confidence intervals for the mean change in MRSE for all non-dominant eyes include zero between all consecutive visits.

Table 6 presents refractive stability data for non-dominant eyes, non-dominant eyes with spherical myopia, and non-dominant eyes with myopic astigmatism, with two consecutive visits.

|  Table 6: Stability of MRSE: Two Consecutive Visits Non-Dominant Eyes (N=137)  |   |   |   |   |
| --- | --- | --- | --- | --- |
|   | Between 1 and 3 Months | Between 3 and 6 Months | Between 6 and 9 Months | Between 9 and 12 Months  |
|  All Non-Dominant Eyes (NDEs) | (n=133) | (n=133) | (n=132) | (n=131)  |
|  Change in MRSE by ≤0.5 D 95% CI | 128 96.2% (91.4, 98.8) | 132 99.2% (95.9, 100) | 131 99.2% (95.9, 100) | 127 96.9% (92.4, 99.2)  |
|  Change in MRSE by ≤1.0 D 95% CI | 132 99.2% (95.9, 100) | 133 100% (97.8, 100) | 132 100% (97.8, 100) | 131 100% (97.7, 100)  |
|  Mean Change in MRSE ± SD 95% CI | -0.02 ± 0.26 (-0.06, 0.03) | -0.03 ± 0.21 (-0.07, 0.01) | 0.00 ± 0.19 (-0.03, 0.04) | -0.03 ± 0.23 (-0.07, 0.01)  |
|  NDEs w/ Spherical Myopia | (n=81) | (n=81) | (n=82) | (n=81)  |
|  Change in MRSE by ≤0.5 D 95% CI | 79 97.5% (91.4, 99.7) | 80 98.8% (93.3, 100) | 81 98.8% (93.4, 100) | 79 97.5% (91.4, 99.7)  |
|  Change in MRSE by ≤1.0 D 95% CI | 81 100% (96.4, 100) | 81 100% (96.4, 100) | 82 100% (96.4, 100) | 81 100% (96.4, 100)  |
|  Mean Change in MRSE ± SD 95% CI | -0.03 ± 0.23 (-0.08, 0.02) | -0.01 ± 0.21 (-0.06, 0.04) | 0.02 ± 0.20 (-0.02, 0.07) | -0.07 ± 0.21 (-0.12, -0.03)  |
|  NDEs w/ Myopic Astigmatism | (n=52) | (n=52) | (n=50) | (n=50)  |
|  Change in MRSE by ≤0.5 D 95% CI | 49 94.2% (84.1, 98.8) | 52 100% (94.4, 100) | 50 100% (94.2, 100) | 48 96.0% (86.3, 99.5)  |
|  Change in MRSE by ≤1.0 D 95% CI | 51 98.1% (89.7, 100) | 52 100% (94.4, 100) | 50 100% (94.2, 100) | 50 100% (94.2, 100)  |
|  Mean Change in MRSE ± SD 95% CI | 0.00 ± 0.31 (-0.09, 0.09) | -0.06 ± 0.20 (-0.12, -0.01) | -0.03 ± 0.18 (-0.08, 0.02) | 0.05 ± 0.24 (-0.02, 0.12)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
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c. Effectiveness Outcomes

The data from one hundred fifty-nine (159) dominant eyes and one hundred thirty-seven (137) non-dominant eyes of one hundred sixty (160) subjects who were enrolled and treated in this study were used to evaluate effectiveness. Effectiveness analyses are also presented separately non-dominant eyes with spherical myopia (eyes with ≤ 0.5 D preoperative manifest cylinder, n=83), and myopic astigmatism (eyes with > 0.5 D preoperative manifest cylinder, n=54). Vector Analyses were conducted at the point of defined stability, 6-months, for non-dominant eyes with myopic astigmatism.

1) Binocular Uncorrected Distance Visual Acuity (UCDVA)

Uncorrected distance visual acuity (UCDVA) was measured under photopic lighting conditions in the subject's dominant eye and binocularly at 4 meters, without any lens correction, using the VectorVision CSV-1000 ETDRS test face. Table 7 presents UCDVA results over time for all subjects. At the 6-month point of stability, 86.7% of subjects achieved an outcome of UCDVA of 20/20 or better.

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
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|  Table 7: Binocular UCDVA Over Time All Subjects (N=160)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=160) | 1 Month (n=159) | 3 Months (n=157) | 6 Months (n=158) | 9 Months (n=152) | 12 Months (n=149)  |
|  Acuity | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI)  |
|  20/12.5 or better | 0 0.0% (0.0, 1.9) | 19 11.9% (7.4, 18.0) | 28 17.8% (12.2, 24.7) | 28 17.7% (12.1, 24.6) | 36 23.7% (17.2, 31.3) | 29 19.5% (13.4, 26.7)  |
|  20/16 or better | 1 0.6% (0.0, 3.4) | 101 63.5% (55.5, 71.0) | 105 66.9% (58.9, 74.2) | 112 70.9% (63.1, 77.8) | 105 69.1% (61.1, 76.3) | 103 69.1% (61.0, 76.4)  |
|  20/20 or better | 1 0.6% (0.0, 3.4) | 137 86.2% (79.8, 91.1) | 138 87.9% (81.7, 92.6) | 137 86.7% (80.4, 91.6) | 142 93.4% (88.2, 96.8) | 138 92.6% (87.2, 96.3)  |
|  20/25 or better | 1 0.6% (0.0, 3.4) | 156 98.1% (94.6, 99.6) | 153 97.5% (93.6, 99.3) | 151 95.6% (91.1, 98.2) | 146 96.1% (91.6, 98.5) | 145 97.3% (93.3, 99.3)  |
|  20/32 or better | 2 1.3% (0.2, 4.4) | 159 100% (98.1, 100) | 155 98.7% (95.5, 99.8) | 156 98.7% (95.5, 99.8) | 151 99.3% (96.4, 100) | 148 99.3% (96.3, 100)  |
|  20/40 or better | 4 2.5% (0.7, 6.3) | 159 100% (98.1, 100) | 156 99.4% (96.5, 100) | 158 100% (98.1, 100) | 152 100% (98.0, 100) | 148 99.3% (96.3, 100)  |
|  20/80 or better | 21 13.1% (8.3, 19.4) | 159 100% (98.1, 100) | 157 100% (98.1, 100) | 158 100% (98.1, 100) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  20/100 or better | 49 30.6% (23.6, 38.4) | 159 100% (98.1, 100) | 157 100% (98.1, 100) | 158 100% (98.1, 100) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  Worse than 20/100 | 111 69.4% (61.6, 76.4) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 2.0) | 0 0.0% (0.0, 2.0)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
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# 2) Binocular Uncorrected Near Visual Acuity Over Time

Uncorrected near visual acuity (UCNVA) was measured under photopic lighting conditions in the subject's non-dominant eye and binocularly at 16 inches without any lens correction, using the ETDRS 40 cm Near card for acuity testing. At least 88% of subjects achieved 20/20 or better near vision at the 3, 6, 9, and 12-month visits. Table 8 presents binocular UCNVA over time.

|  Table 8: Binocular UCNVA Over Time All Subjects N=160  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=160) | 1 Month (n=159) | 3 Months (n=157) | 6 Months (n=158) | 9 Months (n=152) | 12 Months (n=149)  |
|  Acuity | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI)  |
|  20/12.5 or better | 2 1.3% (0.2, 4.4) | 9 5.7% (2.6, 10.5) | 12 7.6% (4.0, 13.0) | 13 8.2% (4.5, 13.7) | 17 11.2% (6.7, 17.3) | 14 9.4% (5.2, 15.3)  |
|  20/16 or better | 30 18.8% (13.0, 25.7) | 69 43.4% (35.6, 51.5) | 79 50.3% (42.2, 58.4) | 71 44.9% (37.0, 53.0) | 74 48.7% (40.5, 56.9) | 66 44.3% (36.2, 52.7)  |
|  20/20 or better | 55 34.4% (27.1, 42.3) | 138 86.8% (80.5, 91.6) | 140 89.2% (83.2, 93.6) | 139 88.0% (81.9, 92.6) | 136 89.5% (83.5, 93.9) | 137 91.9% (86.4, 95.8)  |
|  20/25 or better | 74 46.3% (38.3, 54.3) | 155 97.5% (93.7, 99.3) | 151 96.2% (91.9, 98.6) | 153 96.8% (92.8, 99.0) | 148 97.4% (93.4, 99.3) | 147 98.7% (95.2, 99.8)  |
|  20/32 or better | 82 51.3% (43.2, 59.2) | 158 99.4% (96.5, 100) | 155 98.7% (95.5, 99.8) | 158 100% (98.1, 100) | 151 99.3% (96.4, 100) | 148 99.3% (96.3, 100)  |
|  20/40 or better | 97 60.6% (52.6, 68.2) | 159 100% (98.1, 100) | 157 100% (98.1, 100) | 158 100% (98.1, 100) | 151 99.3% (96.4, 100) | 149 100% (98.0, 100)  |
|  20/80 or better | 140 87.5% (81.4, 92.2) | 159 100% (98.1, 100) | 157 100% (98.1, 100) | 158 100% (98.1, 100) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  20/100 or better | 152 95.0% (90.4, 97.8) | 159 100% (98.1, 100) | 157 100% (98.1, 100) | 158 100% (98.1, 100) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  20/125 or better | 155 96.9% (92.9, 99.0) | 159 100% (98.1, 100) | 157 100% (98.1, 100) | 158 100% (98.1, 100) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  20/160 or better | 157 98.1% (94.6, 99.6) | 159 100% (98.1, 100) | 157 100% (98.1, 100) | 158 100% (98.1, 100) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  20/200 or better | 159 99.4% (96.6, 100) | 159 100% (98.1, 100) | 157 100% (98.1, 100) | 158 100% (98.1, 100) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  Worse than 20/200 | 1 0.6% (0.0, 3.4) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 2.0) | 0 0.0% (0.0, 2.0)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

3) Simultaneous Binocular Uncorrected Distance and Near Visual Acuity Over Time

Approximately 80% of subjects achieved 20/20 or better vision at both distance and near at the 3, 6, 9, and 12-month visits. The percentage of subjects who achieved simultaneous levels of uncorrected visual acuity at both distance and near over time is presented in Table 9.

|  Table 9: Binocular Simultaneous Uncorrected Distance and Uncorrected Near Visual Acuity All Subjects (N=160)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=160) | 1 Month (n=159) | 3 Months (n=157) | 6 Months (n=158) | 9 Months (n=152) | 12 Months (n=149)  |
|   | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI)  |
|  20/20 or better near and 20/20 or better distance | 0 0.0% (0.0, 1.9) | 121 76.1% (68.7, 82.5) | 126 80.3% (73.2, 86.2) | 126 79.7% (72.6, 85.7) | 131 86.2% (79.7, 91.2) | 128 85.9% (79.3, 91.1)  |
|  20/25 or better near and 20/25 or better distance | 0 0.0% (0.0, 1.9) | 152 95.6% (91.1, 98.2) | 148 94.3% (89.4, 97.3) | 146 92.4% (87.1, 96.0) | 144 94.7% (89.9, 97.7) | 144 96.6% (92.3, 98.9)  |
|  20/32 or better near and 20/32 or better distance | 1 0.6% (0.0, 3.4) | 158 99.4% (96.5, 100) | 153 97.5% (93.6, 99.3) | 156 98.7% (95.5, 99.8) | 150 98.7% (95.3, 99.8) | 147 98.7% (95.2, 99.8)  |
|  20/40 or better near and 20/40 or better distance | 4 2.5% (0.7, 6.3) | 159 100% (98.1, 100) | 156 99.4% (96.5, 100) | 158 100% (98.1, 100) | 151 99.3% (96.4, 100) | 148 99.3% (96.3, 100)  |
|  Worse than 20/40 at both distance and near | 156 97.5% (93.7, 99.3) | 0 0.0% (0.0, 1.9) | 1 0.6% (0.0, 3.5) | 0 0.0% (0.0, 1.9) | 1 0.7% (0.0, 3.6) | 1 0.7% (0.0, 3.7)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

# 4) Binocular Uncorrected Intermediate Visual Acuity Over Time

Uncorrected intermediate visual acuity (UCIVA) was measured under photopic lighting conditions binocularly at 60 centimeters without any lens correction, using the ETDRS acuity test for 60 cm. Over 80% of subjects achieved 20/20 or better intermediate vision at the 6, 9, and 12-month visits. Table 10 presents binocular UCIVA over time.

|  Table 10: Binocular UCIVA Over Time All Subjects (N=160)  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|   | 1 Month (n=159) | 3 Months (n=157) | 6 Months (n=158) | 9 Months (n=152) | 12 Months (n=149)  |
|  Acuity | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI)  |
|  20/12.5 or better | 17 10.7% (6.4, 16.6) | 20 12.7% (8.0, 19.0) | 13 8.2% (4.5, 13.7) | 14 9.2% (5.1, 15.0) | 18 12.1% (7.3, 18.4)  |
|  20/16 or better | 65 40.9% (33.2, 48.9) | 75 47.8% (39.7, 55.9) | 79 50.0% (42.0, 58.0) | 84 55.3% (47.0, 63.3) | 77 51.7% (43.4, 59.9)  |
|  20/20 or better | 123 77.4% (70.1, 83.6) | 122 77.7% (70.4, 84.0) | 134 84.8% (78.2, 90.0) | 135 88.8% (82.7, 93.3) | 132 88.6% (82.4, 93.2)  |
|  20/25 or better | 148 93.1% (88.0, 96.5) | 146 93.0% (87.8, 96.5) | 152 96.2% (91.9, 98.6) | 147 96.7% (92.5, 98.9) | 145 97.3% (93.3, 99.3)  |
|  20/32 or better | 155 97.5% (93.7, 99.3) | 153 97.5% (93.6, 99.3) | 156 98.7% (95.5, 99.8) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  20/40 or better | 156 98.1% (94.6, 99.6) | 156 99.4% (96.5, 100) | 156 98.7% (95.5, 99.8) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  20/80 or better | 159 100% (98.1, 100) | 157 100% (98.1, 100) | 158 100% (98.1, 100) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  20/100 or better | 159 100% (98.1, 100) | 157 100% (98.1, 100) | 158 100% (98.1, 100) | 152 100% (98.0, 100) | 149 100% (98.0, 100)  |
|  Worse than 20/100 | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 2.0) | 0 0.0% (0.0, 2.0)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

# 5) Monocular Uncorrected Distance Visual Acuity (UCDVA) Over Time

Monocular UCDVA testing was limited to those treated eyes targeted for emmetropia (dominant eyes). Over 85% of dominant eyes achieved 20/20 or better uncorrected distance vision at the 3, 6, 9, and 12-month visits. Table 11 presents UCDVA distance results over time for all treated dominant eyes.

|  Table 11: Uncorrected Distance Visual Acuity Dominant Eyes (N=159)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=159) | 1 Month (n=158) | 3 Months (n=156) | 6 Months (n=157) | 9 Months (n=151) | 12 Months (n=148)  |
|  Acuity | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI)  |
|  20/12.5 or better | 0 0.0% (0.0, 1.9) | 19 12.0% (7.4, 18.1) | 25 16.0% (10.6, 22.7) | 23 14.6% (9.5, 21.2) | 28 18.5% (12.7, 25.7) | 29 19.6% (13.5, 26.9)  |
|  20/16 or better | 0 0.0% (0.0, 1.9) | 87 55.1% (47.0, 63.0) | 99 63.5% (55.4, 71.0) | 103 65.6% (57.6, 73.0) | 97 64.2% (56.0, 71.9) | 97 65.5% (57.3, 73.2)  |
|  20/20 or better | 0 0.0% (0.0, 1.9) | 134 84.8% (78.2, 90.0) | 134 85.9% (79.4, 90.9) | 138 87.9% (81.7, 92.6) | 136 90.1% (84.1, 94.3) | 132 89.2% (83.0, 93.7)  |
|  20/25 or better | 0 0.0% (0.0, 1.9) | 154 97.5% (93.6, 99.3) | 151 96.8% (92.7, 99.0) | 150 95.5% (91.0, 98.2) | 145 96.0% (91.6, 98.5) | 143 96.6% (92.3, 98.9)  |
|  20/32 or better | 0 0.0% (0.0, 1.9) | 157 99.4% (96.5, 100) | 154 98.7% (95.4, 99.8) | 154 98.1% (94.5, 99.6) | 150 99.3% (96.4, 100) | 147 99.3% (96.3, 100)  |
|  20/40 or better | 0 0.0% (0.0, 1.9) | 158 100% (98.1, 100) | 156 100% (98.1, 100) | 156 99.4% (96.5, 100) | 151 100% (98.0, 100) | 148 100% (98.0, 100)  |
|  20/80 or better | 13 8.2% (4.4, 13.6) | 158 100% (98.1, 100) | 156 100% (98.1, 100) | 157 100% (98.1, 100) | 151 100% (98.0, 100) | 148 100% (98.0, 100)  |
|  20/100 or better | 31 19.5% (13.6, 26.5) | 158 100% (98.1, 100) | 156 100% (98.1, 100) | 157 100% (98.1, 100) | 151 100% (98.0, 100) | 148 100% (98.0, 100)  |
|  Worse than 20/100 | 128 80.5% (73.5, 86.4) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 2.0) | 0 0.0% (0.0, 2.0)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

# 6) Monocular Uncorrected Near Visual Acuity (UCNVA) Over Time

Monocular UCNVA testing was limited to those treated eyes targeted for a myopic outcome (non-dominant eyes). Over 80% of non-dominant eyes achieved 20/20 or better uncorrected near vision at the 3, 6, 9, and 12-month visits. Table 12 presents monocular UCNVA distance results over time for all treated non-dominant eyes.

|  Table 12: Monocular Uncorrected Near Visual Acuity Non-Dominant Eyes (N=137)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=137) | 1 Month (n=136) | 3 Months (n=134) | 6 Months (n=135) | 9 Months (n=133) | 12 Months (n=133)  |
|  Acuity | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI)  |
|  20/12.5 or better | 0 0.0% (0.0, 2.2) | 7 5.1% (2.1, 10.3) | 7 5.2% (2.1, 10.5) | 9 6.7% (3.1, 12.3) | 9 6.8% (3.1, 12.5) | 8 6.0% (2.6, 11.5)  |
|  20/16 or better | 10 7.3% (3.6, 13.0) | 46 33.8% (25.9, 42.4) | 62 46.3% (37.6, 55.1) | 58 43.0% (34.5, 51.8) | 58 43.6% (35.0, 52.5) | 49 36.8% (28.6, 45.6)  |
|  20/20 or better | 25 18.2% (12.2, 25.7) | 102 75.0% (66.9, 82.0) | 113 84.3% (77.0, 90.0) | 109 80.7% (73.1, 87.0) | 116 87.2% (80.3, 92.4) | 114 85.7% (78.6, 91.2)  |
|  20/25 or better | 44 32.1% (24.4, 40.6) | 128 94.1% (88.7, 97.4) | 127 94.8% (89.5, 97.9) | 129 95.6% (90.6, 98.4) | 129 97.0% (92.5, 99.2) | 130 97.7% (93.5, 99.5)  |
|  20/32 or better | 54 39.4% (31.2, 48.1) | 133 97.8% (93.7, 99.5) | 130 97.0% (92.5, 99.2) | 135 100% (97.8, 100) | 133 100% (97.8, 100) | 130 97.7% (93.5, 99.5)  |
|  20/40 or better | 63 46.0% (37.4, 54.7) | 136 100% (97.8, 100) | 133 99.3% (95.9, 100) | 135 100% (97.8, 100) | 133 100% (97.8, 100) | 132 99.2% (95.9, 100)  |
|  20/80 or better | 100 73.0% (64.7, 80.2) | 136 100% (97.8, 100) | 134 100% (97.8, 100) | 135 100% (97.8, 100) | 133 100% (97.8, 100) | 133 100% (97.8, 100)  |
|  20/100 or better | 114 83.2% (75.9, 89.0) | 136 100% (97.8, 100) | 134 100% (97.8, 100) | 135 100% (97.8, 100) | 133 100% (97.8, 100) | 133 100% (97.8, 100)  |
|  20/125 or better | 126 92.0% (86.1, 95.9) | 136 100% (97.8, 100) | 134 100% (97.8, 100) | 135 100% (97.8, 100) | 133 100% (97.8, 100) | 133 100% (97.8, 100)  |
|  20/160 or better | 130 94.9% (89.8, 97.9) | 136 100% (97.8, 100) | 134 100% (97.8, 100) | 135 100% (97.8, 100) | 133 100% (97.8, 100) | 133 100% (97.8, 100)  |
|  20/200 or better | 136 99.3% (96.0, 100) | 136 100% (97.8, 100) | 134 100% (97.8, 100) | 135 100% (97.8, 100) | 133 100% (97.8, 100) | 133 100% (97.8, 100)  |
|  Worse than 20/200 | 1 0.7% (0.0, 4.0) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2)  |
|  Not Reported | 0 | 0 | 0 | 0 | 0 | 0  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

Table 13 presents monocular UCNVA distance results over time for all treated non-dominant eyes with spherical myopia.

|  Table 13: Monocular Uncorrected Near Visual Acuity Non-Dominant Eyes with Spherical Myopia (N=83)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=83) | 1 Month (n=82) | 3 Months (n=82) | 6 Months (n=82) | 9 Months (n=83) | 12 Months (n=81)  |
|  Acuity | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI)  |
|  20/12.5 or better | 0 0.0% (0.0, 3.5) | 4 4.9% (1.3, 12.0) | 5 6.1% (2.0, 13.7) | 6 7.3% (2.7, 15.2) | 6 7.2% (2.7, 15.1) | 4 4.9% (1.4, 12.2)  |
|  20/16 or better | 8 9.6% (4.3, 18.1) | 26 31.7% (21.9, 42.9) | 39 47.6% (36.4, 58.9) | 35 42.7% (31.8, 54.1) | 34 41.0% (30.3, 52.3) | 29 35.8% (25.4, 47.2)  |
|  20/20 or better | 19 22.9% (14.4, 33.4) | 65 79.3% (68.9, 87.4) | 70 85.4% (75.8, 92.2) | 68 82.9% (73.0, 90.3) | 71 85.5% (76.1, 92.3) | 69 85.2% (75.6, 92.1)  |
|  20/25 or better | 35 42.2% (31.4, 53.5) | 78 95.1% (88.0, 98.7) | 78 95.1% (88.0, 98.7) | 79 96.3% (89.7, 99.2) | 80 96.4% (89.8, 99.2) | 79 97.5% (91.4, 99.7)  |
|  20/32 or better | 39 47.0% (35.9, 58.3) | 81 98.8% (93.4, 100) | 81 98.8% (93.4, 100) | 82 100% (96.4, 100) | 83 100% (96.5, 100) | 79 97.5% (91.4, 99.7)  |
|  20/40 or better | 41 49.4% (38.2, 60.6) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 83 100% (96.5, 100) | 81 100% (96.4, 100)  |
|  20/80 or better | 58 69.9% (58.8, 79.5) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 83 100% (96.5, 100) | 81 100% (96.4, 100)  |
|  20/100 or better | 67 80.7% (70.6, 88.6) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 83 100% (96.5, 100) | 81 100% (96.4, 100)  |
|  20/125 or better | 75 90.4% (81.9, 95.7) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 83 100% (96.5, 100) | 81 100% (96.4, 100)  |
|  20/160 or better | 78 94.0% (86.5, 98.0) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 83 100% (96.5, 100) | 81 100% (96.4, 100)  |
|  20/200 or better | 82 98.8% (93.5, 100) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 83 100% (96.5, 100) | 81 100% (96.4, 100)  |
|  Worse than 20/200 | 1 1.2% (0.0, 6.5) | 0 0.0% (0.0, 3.6) | 0 0.0% (0.0, 3.6) | 0 0.0% (0.0, 3.6) | 0 0.0% (0.0, 3.5) | 0 0.0% (0.0, 3.6)  |
|  Not Reported | 0 | 0 | 0 | 0 | 0 | 0  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

Table 14 presents monocular UCNVA distance results over time for all treated non-dominant eyes with myopic astigmatism.

|  Table 14: Monocular Uncorrected Near Visual Acuity Non-Dominant Eyes with Myopic Astigmatism (N=54)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=54) | 1 Month (n=54) | 3 Months (n=52) | 6 Months (n=53) | 9 Months (n=50) | 12 Months (n=52)  |
|  Acuity | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI) | n % (95% CI)  |
|  20/12.5 or better | 0 0.0% (0.0, 5.4) | 3 5.6% (1.2, 15.4) | 2 3.8% (0.5, 13.2) | 3 5.7% (1.2, 15.7) | 3 6.0% (1.3, 16.5) | 4 7.7% (2.1, 18.5)  |
|  20/16 or better | 2 3.7% (0.5, 12.7) | 20 37.0% (24.3, 51.3) | 23 44.2% (30.5, 58.7) | 23 43.4% (29.8, 57.7) | 24 48.0% (33.7, 62.6) | 20 38.5% (25.3, 53.0)  |
|  20/20 or better | 6 11.1% (4.2, 22.6) | 37 68.5% (54.4, 80.5) | 43 82.7% (69.7, 91.8) | 41 77.4% (63.8, 87.7) | 45 90.0% (78.2, 96.7) | 45 86.5% (74.2, 94.4)  |
|  20/25 or better | 9 16.7% (7.9, 29.3) | 50 92.6% (82.1, 97.9) | 49 94.2% (84.1, 98.8) | 50 94.3% (84.3, 98.8) | 49 98.0% (89.4, 99.9) | 51 98.1% (89.7, 100)  |
|  20/32 or better | 15 27.8% (16.5, 41.6) | 52 96.3% (87.3, 99.5) | 49 94.2% (84.1, 98.8) | 53 100% (94.5, 100) | 50 100% (94.2, 100) | 51 98.1% (89.7, 100)  |
|  20/40 or better | 22 40.7% (27.6, 55.0) | 54 100% (94.6, 100) | 51 98.1% (89.7, 100) | 53 100% (94.5, 100) | 50 100% (94.2, 100) | 51 98.1% (89.7, 100)  |
|  20/80 or better | 42 77.8% (64.4, 88.0) | 54 100% (94.6, 100) | 52 100% (94.4, 100) | 53 100% (94.5, 100) | 50 100% (94.2, 100) | 52 100% (94.4, 100)  |
|  20/100 or better | 47 87.0% (75.1, 94.6) | 54 100% (94.6, 100) | 52 100% (94.4, 100) | 53 100% (94.5, 100) | 50 100% (94.2, 100) | 52 100% (94.4, 100)  |
|  20/125 or better | 51 94.4% (84.6, 98.8) | 54 100% (94.6, 100) | 52 100% (94.4, 100) | 53 100% (94.5, 100) | 50 100% (94.2, 100) | 52 100% (94.4, 100)  |
|  20/160 or better | 52 96.3% (87.3, 99.5) | 54 100% (94.6, 100) | 52 100% (94.4, 100) | 53 100% (94.5, 100) | 50 100% (94.2, 100) | 52 100% (94.4, 100)  |
|  20/200 or better | 54 100% (94.6, 100) | 54 100% (94.6, 100) | 52 100% (94.4, 100) | 53 100% (94.5, 100) | 50 100% (94.2, 100) | 52 100% (94.4, 100)  |
|  Worse than 20/200 | 0 0.0% (0.0, 5.4) | 0 0.0% (0.0, 5.4) | 0 0.0% (0.0, 5.6) | 0 0.0% (0.0, 5.5) | 0 0.0% (0.0, 5.8) | 0 0.0% (0.0, 5.6)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

Six months postoperatively, one half of the study subjects (50.6%, 80/158) were able to see as well or better at near with no correction as they could see using best correction for near in both eyes preoperatively. Table 15 presents post-operative uncorrected distance near visual acuity compared to pre-operative best-corrected distance near visual acuity over time for all subjects.

|  Table 15: Post-Operative Binocular UCNVA Compared to Pre-Operative Binocular BCNVA All Subjects (N=160)  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|   | 1 Month (n=159) | 3 Month (n=157) | 6 Months (n=158) | 9 Months (n=152) | 12 Months (n=149)  |
|   | n % 95% CI | n % 95% CI | n % 95% CI | n % 95% CI | n % 95% CI  |
|  >2 lines better | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 2.0) | 0 0.0% (0.0, 2.0)  |
|  2 lines better | 2 1.3% (0.2, 4.5) | 2 1.3% (0.2, 4.5) | 3 1.9% (0.4, 5.4) | 3 2.0% (0.4, 5.7) | 3 2.0% (0.4, 5.8)  |
|  1 line better | 12 7.5% (4.0, 12.8) | 17 10.8% (6.4, 16.8) | 17 10.8% (6.4, 16.7) | 20 13.2% (8.2, 19.6) | 16 10.7% (6.3, 16.9)  |
|  <1 line change | 61 38.4% (30.8, 46.4) | 66 42.0% (34.2, 50.2) | 60 38.0% (30.4, 46.0) | 61 40.1% (32.3, 48.4) | 59 39.6% (31.7, 47.9)  |
|  1 line worse | 62 39.0% (31.4, 47.0) | 45 28.7% (21.7, 36.4) | 49 31.0% (23.9, 38.8) | 44 28.9% (21.9, 36.8) | 46 30.9% (23.6, 39.0)  |
|  2 lines worse | 16 10.1% (5.9, 15.8) | 22 14.0% (9.0, 20.4) | 25 15.8% (10.5, 22.5) | 19 12.5% (7.7, 18.8) | 23 15.4% (10.0, 22.3)  |
|  >2 lines worse | 6 3.8% (1.4, 8.0) | 5 3.2% (1.0, 7.3) | 4 2.5% (0.7, 6.4) | 5 3.3% (1.1, 7.5) | 2 1.3% (0.2, 4.8)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

# 7) Accuracy

Tables 16, 17, 18 and 19 present the accuracy of sphere and cylinder over time for all dominant eyes, all non-dominant eyes, non-dominant eyes with spherical myopia, and non-dominant eyes with myopic astigmatism, respectively. Accuracy of cylinder analysis is limited to eyes with myopic astigmatism.

At 6 months post-operatively, 89.8% (141/157) of dominant eyes were within 0.5 D and 98.7% (155/157) were within 1.0 D of attempted sphere correction. Additionally, 83.6% (61/73) of dominant eyes were within 0.5 D and 95.9% (70/73) were within 1.0 D of attempted cylinder correction. Table 16 presents the accuracy of sphere and cylinder over time for all dominant eyes.

|  Table 16: Accuracy of Sphere and Cylinder Component Dominant Eyes (N=159)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op | 1 Month | 3 Months | 6 Months | 9 Months | 12 Months  |
|   | n % | n % | n % | n % | n % | n %  |
|  **Sphere** | n=159 | n=158 | n=156 | n=157 | n=151 | n=148  |
|  ± 0.50 D 95% CI | 0 0.0% (0.0, 1.9) | 138 87.3% (81.1, 92.1) | 137 87.8% (81.6, 92.5) | 141 89.8% (84.0, 94.1) | 136 90.1% (84.1, 94.3) | 130 87.8% (81.5, 92.6)  |
|  ± 1.00 D 95% CI | 3 1.9% (0.4, 5.4) | 153 96.8% (92.8, 99.0) | 154 98.7% (95.4, 99.8) | 155 98.7% (95.5, 99.8) | 149 98.7% (95.3, 99.8) | 148 100% (98.0, 100)  |
|  Mean ± SD | -3.50 ± 1.24 | 0.08 ± 0.41 | 0.00 ± 0.41 | -0.03 ± 0.41 | -0.09 ± 0.38 | -0.11 ± 0.39  |
|  Attempted |  | -3.50 ± 1.24 | -3.50 ± 1.25 | -3.50 ± 1.24 | -3.55 ± 1.23 | -3.49 ± 1.26  |
|  Achieved |  | -3.58 ± 1.22 | -3.50 ± 1.24 | -3.47 ± 1.21 | -3.45 ± 1.22 | -3.38 ± 1.25  |
|  % Achieved |  | 104.0% | 100.8% | 100.4% | 97.8% | 97.2%  |
|  **Cylinder^** | n=73 | n=73 | n=71 | n=73 | n=67 | n=66  |
|  ± 0.50 D 95% CI | 0 0.0% (0.0, 4.0) | 65 89.0% (79.5, 95.1) | 64 90.1% (80.7, 95.9) | 61 83.6% (73.0, 91.2) | 56 83.6% (72.5, 91.5) | 62 93.9% (85.2, 98.3)  |
|  ± 1.00 D 95% CI | 46 63.0% (50.9, 74.0) | 73 100% (96.0, 100) | 71 100% (95.9, 100) | 70 95.9% (88.5, 99.1) | 67 100% (95.6, 100) | 66 100% (95.6, 100)  |
|  Mean ± SD | -1.10 ± 0.45 | -0.27 ± 0.29 | -0.27 ± 0.29 | -0.28 ± 0.35 | -0.26 ± 0.30 | -0.19 ± 0.28  |
|  Attempted |  | -1.10 ± 0.45 | -1.08 ± 0.44 | -1.10 ± 0.45 | -1.07 ± 0.45 | -1.11 ± 0.46  |
|  Achieved |  | -0.82 ± 0.50 | -0.81 ± 0.48 | -0.82 ± 0.51 | -0.81 ± 0.50 | -0.92 ± 0.47  |
|  % Achieved |  | 72.7% | 72.9% | 73.4% | 73.9% | 83.6%  |

^ Cylinder analysis limited to those eyes with pre-op manifest cylinder >0.5 D (N=73)

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

At 6 months post-operatively, 89.6% (121/135) of non-dominant eyes were within 0.5 D and 99.3% (134/135) were within 1.0 D of attempted sphere correction. Additionally, 90.6% (48/53) of non-dominant eyes were within 0.5 D and 98.1% (52/53) were within 1.0 D of attempted cylinder correction. Table 17 presents the accuracy of sphere and cylinder over time for all non-dominant eyes.

|  Table 17: Accuracy of Sphere and Cylinder Components Non-Dominant Eyes (N=137)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=137) | 1 Month (n=136) | 3 Months (n=134) | 6 Months (n=135) | 9 Months (n=133) | 12 Months (n=133)  |
|  Sphere | n % | n % | n % | n % | n % | n %  |
|  ± 0.50 D 95% CI | 7 5.1% (2.1, 10.2) | 123 90.4% (84.2, 94.8) | 121 90.3% (84.0, 94.7) | 121 89.6% (83.2, 94.2) | 121 91.0% (84.8, 95.3) | 121 91.0% (84.8, 95.3)  |
|  ± 1.00 D 95% CI | 27 19.7% (13.4, 27.4) | 135 99.3% (96.0, 100) | 132 98.5% (94.7, 99.8) | 134 99.3% (95.9, 100) | 131 98.5% (94.7, 99.8) | 131 98.5% (94.7, 99.8)  |
|  Mean ± SD | -3.83 ± 1.06 | -1.74 ± 0.45 | -1.75 ± 0.45 | -1.78 ± 0.46 | -1.79 ± 0.46 | -1.82 ± 0.46  |
|  Attempted |  | -2.11 ± 1.04 | -2.10 ± 1.04 | -2.11 ± 1.04 | -2.15 ± 1.02 | -2.12 ± 1.04  |
|  Achieved |  | -2.10 ± 1.09 | -2.07 ± 1.03 | -2.05 ± 1.02 | -2.09 ± 1.01 | -2.01 ± 1.04  |
|  % Achieved |  | 98.7% | 101.2% | 99.7% | 98.1% | 95.3%  |
|  Cylinder^ | n=54 | n=54 | n=52 | n=53 | n=50 | n=52  |
|  ± 0.50 D 95% CI | 0 0.0% (0.0, 5.4) | 49 90.7% (79.7, 96.9) | 46 88.5% (76.6, 95.6) | 48 90.6% (79.3, 96.9) | 46 92.0% (80.8, 97.8) | 47 90.4% (79.0, 96.8)  |
|  ± 1.00 D 95% CI | 25 46.3% (32.6, 60.4) | 53 98.1% (90.1, 100) | 51 98.1% (89.7, 100) | 52 98.1% (89.9, 100) | 50 100% (94.2, 100) | 51 98.1% (89.7, 100)  |
|  Mean ± SD | -1.20 ± 0.46 | -0.26 ± 0.29 | -0.27 ± 0.32 | -0.24 ± 0.32 | -0.24 ± 0.29 | -0.23 ± 0.29  |
|  Attempted |  | -1.20 ± 0.46 | -1.19 ± 0.45 | -1.21 ± 0.46 | -1.18 ± 0.45 | -1.19 ± 0.45  |
|  Achieved |  | -0.94 ± 0.54 | -0.92 ± 0.49 | -0.97 ± 0.55 | -0.94 ± 0.53 | -0.96 ± 0.52  |
|  % Achieved |  | 74.6% | 75.0% | 76.9% | 76.6% | 77.6%  |

^ Cylinder analysis limited to those eyes with pre-op manifest cylinder >0.5 D (N=54).

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

Table 18 presents the accuracy of sphere and cylinder over time for all treated non-dominant eyes with spherical myopia.

|  Table 18: Accuracy of Sphere (to Target) and Cylinder (to Zero) Component Non-Dominant Eyes with Spherical Myopia (N=83)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=83) | 1 Month (n=82) | 3 Months (n=82) | 6 Months (n=82) | 9 Months (n=83) | 12 Months (n=81)  |
|  Sphere | n % | n % | n % | n % | n % | n %  |
|  ± 0.50 D 95% CI | 1 1.2% (0.0, 6.5) | 76 92.7% (84.8, 97.3) | 73 89.0% (80.2, 94.9) | 70 85.4% (75.8, 92.2) | 73 88.0% (79.0, 94.1) | 74 91.4% (83.0, 96.5)  |
|  ± 1.00 D 95% CI | 13 15.7% (8.6, 25.3) | 82 100% (96.4, 100) | 81 98.8% (93.4, 100) | 82 100% (96.4, 100) | 82 98.8% (93.5, 100) | 80 98.8% (93.3, 100)  |
|  Mean ± SD | -3.96 ± 1.02 | -1.75 ± 0.44 | -1.77 ± 0.44 | -1.77 ± 0.45 | -1.75 ± 0.47 | -1.85 ± 0.46  |
|  Attempted | - | -2.24 ± 1.04 | -2.22 ± 1.03 | -2.23 ± 1.04 | -2.24 ± 1.04 | -2.23 ± 1.04  |
|  Achieved | - | -2.21 ± 1.04 | -2.17 ± 1.00 | -2.18 ± 1.00 | -2.21 ± 1.01 | -2.10 ± 1.01  |
|  % Achieved | - | 101.1% | 100.4% | 100.4% | 102.0% | 95.2%  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

Table 19 presents the accuracy of sphere and cylinder over time for all treated non-dominant eyes with myopic astigmatism.

|  Table 19: Accuracy of Sphere (to Target) and Cylinder (to Zero) Component Non-Dominant Eyes with Myopic Astigmatism (N=54)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op n=54 | 1 Month n=54 | 3 Months n=52 | 6 Months n=53 | 9 Months n=50 | 12 Months n=52  |
|  Sphere | n % | n % | n % | n % | n % | n %  |
|  ± 0.50 D 95% CI | 6 11.1% (4.2, 22.6) | 47 87.0% (75.1, 94.6) | 48 92.3% (81.5, 97.9) | 51 96.2% (87.0, 99.5) | 48 96.0% (86.3, 99.5) | 47 90.4% (79.0, 96.8)  |
|  ± 1.00 D 95% CI | 14 25.9% (15.0, 39.7) | 53 98.1% (90.1, 100) | 51 98.1% (89.7, 100) | 52 98.1% (89.9, 100) | 49 98.0% (89.4, 99.9) | 51 98.1% (89.7, 100)  |
|  Mean ± SD | -3.63 ± 1.09 | -1.71 ± 0.48 | -1.71 ± 0.47 | -1.79 ± 0.48 | -1.85 ± 0.43 | -1.78 ± 0.48  |
|  Attempted | - | -1.91 ± 1.02 | -1.92 ± 1.03 | -1.93 ± 1.02 | -2.01 ± 0.99 | -1.94 ± 1.03  |
|  Achieved | - | -1.91 ± 1.15 | -1.92 ± 1.06 | -1.86 ± 1.02 | -1.89 ± 1.00 | -1.87 ± 1.08  |
|  % Achieved | - | 95.1% | 102.6% | 98.6% | 91.7% | 95.4%  |
|  Cylinder | n=54 | n=54 | n=52 | n=53 | n=50 | n=52  |
|  ± 0.50 D 95% CI | 0 0.0% (0.0, 5.4) | 49 90.7% (79.7, 96.9) | 46 88.5% (76.6, 95.6) | 48 90.6% (79.3, 96.9) | 46 92.0% (80.8, 97.8) | 47 90.4% (79.0, 96.8)  |
|  ± 1.00 D 95% CI | 25 46.3% (32.6, 60.4) | 53 98.1% (90.1, 100) | 51 98.1% (89.7, 100) | 52 98.1% (89.9, 100) | 50 100% (94.2, 100) | 51 98.1% (89.7, 100)  |
|  Mean ± SD | -1.20 ± 0.46 | -0.26 ± 0.29 | -0.27 ± 0.32 | -0.24 ± 0.32 | -0.24 ± 0.29 | -0.23 ± 0.29  |
|  Attempted |  | -1.20 ± 0.46 | -1.19 ± 0.45 | -1.21 ± 0.46 | -1.18 ± 0.45 | -1.19 ± 0.45  |
|  Achieved |  | -0.94 ± 0.54 | -0.92 ± 0.49 | -0.97 ± 0.55 | -0.94 ± 0.53 | -0.96 ± 0.52  |
|  % Achieved |  | 74.6% | 75.0% | 76.9% | 76.6% | 77.6%  |

Tables 20, 21, 22 and 23 present the accuracy of manifest refraction spherical equivalent over time for all dominant eyes, all non-dominant eyes, non-dominant eyes with spherical myopia, and non-dominant eyes with myopic astigmatism, respectively.

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

At 6-months, 88.5% of dominant eyes were within 0.50 D and 98.1% of eyes were within 1.0 D of intended correction. Table 20 provides the accuracy of the intended treatment in dominant eyes.

|  Table 20: Accuracy of MRSE: Intended vs. Achieved Dominant Eyes (N=159)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=159) | 1 Month (n=158) | 3 Months (n=156) | 6 Months (n=157) | 9 Months (n=151) | 12 Months (n=148)  |
|  MRSE | n % | n % | n % | n % | n % | n %  |
|  ± 0.50 D 95% CI | 0 0.0% (0.0, 1.9) | 141 89.2% (83.3, 93.6) | 137 87.8% (81.6, 92.5) | 139 88.5% (82.5, 93.1) | 135 89.4% (83.4, 93.8) | 133 89.9% (83.8, 94.2)  |
|  ± 1.00 D 95% CI | 1 0.6% (0.0, 3.5) | 156 98.7% (95.5, 99.8) | 155 99.4% (96.5, 100) | 154 98.1% (94.5, 99.6) | 150 99.3% (96.4, 100) | 147 99.3% (96.3, 100)  |
|  ± 2.00 D 95% CI | 13 8.2% (4.4, 13.6) | 158 100% (98.1, 100) | 156 100% (98.1, 100) | 157 100% (98.1, 100) | 151 100% (98.0, 100) | 148 100% (98.0, 100)  |
|  Not Reported | 0 | 0 | 0 | 0 | 0 | 0  |
|  Overcorrected  |   |   |   |   |   |   |
|  > 1.00 D 95% CI |  | 2 1.3% (0.2, 4.5) | 0 0.0% (0.0, 1.9) | 2 1.3% (0.2, 4.5) | 0 0.0% (0.0, 2.0) | 0 0.0% (0.0, 2.0)  |
|  > 2.00 D 95% CI |  | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 2.0) | 0 0.0% (0.0, 2.0)  |
|  Undercorrected  |   |   |   |   |   |   |
|  < -1.00 D 95% CI |  | 0 0.0% (0.0, 1.9) | 1 0.6% (0.0, 3.5) | 1 0.6% (0.0, 3.5) | 1 0.7% (0.0, 3.6) | 1 0.7% (0.0, 3.7)  |
|  < -2.00 D 95% CI |  | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 1.9) | 0 0.0% (0.0, 2.0) | 0 0.0% (0.0, 2.0)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

All non-dominant eyes were intentionally undercorrected to achieve good near vision. At 6 months post-operatively, 87.4% (118/135) of eyes were within 0.5 D and 99.3% (134/135) were within 1.0 D of attempted correction. No eye was overcorrected or undercorrected by more than 2.0 diopters. Table 21 presents the accuracy of MRSE results in treated non-dominant eyes.

|  Table 21: Accuracy of MRSE: Intended vs. Achieved Non-Dominant Eyes (N=137)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=137) | 1 Month (n=136) | 3 Months (n=134) | 6 Months (n=135) | 9 Months (n=133) | 12 Months (n=133)  |
|  MRSE | n % | n % | n % | n % | n % | n %  |
|  ± 0.25 D 95% CI |  |  |  | 83 61.5% (52.7, 69.7) |  |   |
|  ± 0.50 D 95% CI | 0 0.0% (0.0, 2.2) | 120 88.2% (81.6, 93.1) | 120 89.6% (83.1, 94.2) | 118 87.4% (80.6, 92.5) | 117 88.0% (81.2, 93.0) | 115 86.5% (79.5, 91.8)  |
|  ± 1.00 D 95% CI | 10 7.3% (3.6, 13.0) | 135 99.3% (96.0, 100) | 132 98.5% (94.7, 99.8) | 134 99.3% (95.9, 100) | 132 99.2% (95.9, 100) | 130 97.7% (93.5, 99.5)  |
|  ± 2.00 D 95% CI | 58 42.3% (33.9, 51.1) | 136 100% (97.8, 100) | 134 100% (97.8, 100) | 135 100% (97.8, 100) | 133 100% (97.8, 100) | 133 100% (97.8, 100)  |
|  Not Reported | 0 | 0 | 0 | 0 | 0 | 0  |
|  Overcorrected  |   |   |   |   |   |   |
|  > 1.00 D 95% CI |  | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 1 0.8% (0.0, 4.1)  |
|  > 2.00 D 95% CI |  | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2)  |
|  Undercorrected  |   |   |   |   |   |   |
|  < -1.00 D 95% CI |  | 1 0.7% (0.0, 4.0) | 2 1.5% (0.2, 5.3) | 1 0.7% (0.0, 4.1) | 1 0.8% (0.0, 4.1) | 2 1.5% (0.2, 5.3)  |
|  < -2.00 D 95% CI |  | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2) | 0 0.0% (0.0, 2.2)  |

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# SUMMARY OF SAFETY AND EFFECTIVENESS DATA
FOR A SUPPLEMENTAL PREMARKET APPROVAL APPLICATION

Table 22 presents the accuracy of MRSE results in treated non-dominant eyes with spherical myopia.

|  Table 22: Accuracy of MRSE: Intended vs. Achieved Non-Dominant Eyes with Spherical Myopia (N=83)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   | Pre-Op (n=83) | 1 Month (n=82) | 3 Months (n=82) | 6 Months (n=82) | 9 Months (n=83) | 12 Months (n=81)  |
|  MRSE | n % | n % | n % | n % | n % | n %  |
|  ± 0.50 D 95% CI | 0 0.0% (0.0, 3.5) | 73 89.0% (80.2, 94.9) | 72 87.8% (78.7, 94.0) | 68 82.9% (73.0, 90.3) | 72 86.7% (77.5, 93.2) | 70 86.4% (77.0, 93.0)  |
|  ± 1.00 D 95% CI | 5 6.0% (2.0, 13.5) | 82 100% (96.4, 100) | 81 98.8% (93.4, 100) | 82 100% (96.4, 100) | 83 100% (96.5, 100) | 80 98.8% (93.3, 100)  |
|  ± 2.00 D 95% CI | 40 48.2% (37.1, 59.4) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 82 100% (96.4, 100) | 83 100% (96.5, 100) | 81 100% (96.4, 100)  |
|  Not Reported | 0 | 0 | 0 | 0 | 0 | 0  |
|  Overcorrected  |   |   |   |   |   |   |
|  > 1.00 D 95% CI |  | 0 0.0% (0.0, 3.6) | 0 0.0% (0.0, 3.6) | 0 0.0% (0.0, 3.6) | 0 0.0% (0.0, 3.5) | 1 1.2% (0.0, 6.7)  |
|  > 2.00 D 95% CI |  | 0 0.0% (0.0, 3.6) | 0 0.0% (0.0, 3.6) | 0 0.0% (0.0, 3.6) | 0 0.0% (0.0, 3.5) | 0 0.0% (0.0, 3.6)  |
|…

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**Source:** [https://fda-staging.innolitics.com/device/P930016S025](https://fda-staging.innolitics.com/device/P930016S025)

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