Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3600](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3600) → POE — Extended Depth Of Focus Intraocular Lens

# POE · Extended Depth Of Focus Intraocular Lens

_Ophthalmic · 21 CFR 886.3600 · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/POE

## Overview

- **Product Code:** POE
- **Device Name:** Extended Depth Of Focus Intraocular Lens
- **Regulation:** [21 CFR 886.3600](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3600)
- **Device Class:** 3
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **Implant:** yes

## Identification

An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

## Classification Rationale

Class III.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P210005](/device/P210005.md) | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | Jul 22, 2022 | APPR |
| [P930014S126](/device/P930014S126.md) | AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A | Alcon Laboratories, Inc. | Feb 26, 2020 | APPR |
| [P980040S065](/device/P980040S065.md) | TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS | Johnson & Johnson Surgical Vision, Inc. | Jul 15, 2016 | APPR |

## Top Applicants

- Acu Focus, Inc. — 1 clearance
- Alcon Laboratories, Inc. — 1 clearance
- Johnson & Johnson Surgical Vision, Inc. — 1 clearance

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**Source:** [https://fda-staging.innolitics.com/productcode/POE](https://fda-staging.innolitics.com/productcode/POE)

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