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) → HQL — Intraocular Lens

# HQL · Intraocular Lens

_Ophthalmic · 21 CFR 886.3600 · Class 3_

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

## Overview

- **Product Code:** HQL
- **Device Name:** 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 (20 of 65)

Showing 20 most recent of 65 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P240038](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P240038.md) | FINEVISION HP Trifocal IOLs | Beaver Visitec International, Inc. | Sep 10, 2025 | APPR |
| [P190018](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P190018.md) | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens | Alcon Laboratories, LLC | Jan 7, 2020 | APPR |
| [P100016](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P100016.md) | EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL | Carl Zeiss Meditec Production, LLC | Oct 19, 2010 | APPR |
| [P090022](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P090022.md) | LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS | Lenstec, Inc. | Apr 12, 2010 | APPR |
| [P080021](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P080021.md) | XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | Bausch & Lomb, Incorporated | Feb 2, 2009 | APPR |
| [P080004](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P080004.md) | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS | Hoya Surgical Optics, Inc. | Sep 26, 2008 | APPR |
| [P060022](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P060022.md) | AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT | Bausch & Lomb, Inc. | Sep 5, 2008 | APPR |
| [P060011](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P060011.md) | C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) | Rayner Intraocular Lenses , Ltd. | May 3, 2007 | APPR |
| [P010027](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P010027.md) | ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT) | Aaren Scientific | Nov 21, 2001 | APWD |
| [P990080](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P990080.md) | CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A | Johnson & Johnson Surgical Vision, Inc. | Apr 5, 2001 | APPR |
| [P990013](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P990013.md) | COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | Starr Surgical Co. | Apr 2, 2000 | APPR |
| [P980040](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P980040.md) | SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | Johnson & Johnson Surgical Vision, Inc. | Feb 3, 2000 | APPR |
| [P990014](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P990014.md) | HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | Bausch & Lomb, Inc. | Nov 12, 1999 | APWD |
| [P970034](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P970034.md) | MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES | Aaren Scientific | Sep 25, 1998 | APWD |
| [P960036](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P960036.md) | MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A) | Ioltech, S.A. | Dec 22, 1997 | APWD |
| [P940007](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P940007.md) | PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL | Advanced Medical Optics, Inc. | Jul 20, 1995 | APWD |
| [P930014](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P930014.md) | ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES | Alcon Laboratories, Inc. | Dec 22, 1994 | APPR |
| [P910061](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P910061.md) | MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS | Bausch & Lomb | Sep 2, 1994 | APPR |
| [P890056](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/P890056.md) | MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS | Advanced Medical Optics, Inc. | May 26, 1994 | APWD |
| [K914311](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQL/K914311.md) | CHIROFLEX II LENS MICROSERT(TM) | Chiron Ophthalmics | Jan 27, 1992 | SESE |

## Top Applicants

- Bausch & Lomb, Inc. — 11 clearances
- Advanced Medical Optics, Inc. — 8 clearances
- Alcon Laboratories — 5 clearances
- Bausch & Lomb — 4 clearances
- Johnson & Johnson Surgical Vision, Inc. — 3 clearances

---

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

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