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) → MFK — Lens, Multifocal Intraocular

# MFK · Lens, Multifocal Intraocular

_Ophthalmic · 21 CFR 886.3600 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MFK

## Overview

- **Product Code:** MFK
- **Device Name:** Lens, Multifocal Intraocular
- **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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P240005](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MFK/P240005.md) | enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | Oct 10, 2024 | APPR |
| [P200020](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MFK/P200020.md) | SBL-3 Multifocal Intraocular Lens | Lenstec, Inc. | Jul 22, 2022 | APPR |
| [P080010](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MFK/P080010.md) | TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | Johnson & Johnson Surgical Vision, Inc. | Jan 16, 2009 | APPR |
| [P040020](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MFK/P040020.md) | ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL | Alcon Research, Ltd. | Mar 21, 2005 | APPR |
| [P960028](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MFK/P960028.md) | AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS | Johnson & Johnson Surgical Vision, Inc. | Sep 5, 1997 | APPR |

## Top Applicants

- Johnson & Johnson Surgical Vision, Inc. — 2 clearances
- Lenstec, Inc. — 1 clearance
- Bausch & Lomb, Inc. — 1 clearance
- Alcon Research, Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MFK](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MFK)

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