HQL · Intraocular Lens
Ophthalmic · 21 CFR 886.3600 · Class 3
Overview
| Product Code | HQL |
|---|---|
| Device Name | Intraocular Lens |
| Regulation | 21 CFR 886.3600 |
| Device Class | Class 3 |
| Review Panel | Ophthalmic |
| 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 | FINEVISION HP Trifocal IOLs | Beaver Visitec International, Inc. | Sep 10, 2025 | APPR |
| P190018 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens | Alcon Laboratories, LLC | Jan 7, 2020 | APPR |
| P100016 | EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL | Carl Zeiss Meditec Production, LLC | Oct 19, 2010 | APPR |
| P090022 | LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS | Lenstec, Inc. | Apr 12, 2010 | APPR |
| P080021 | XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | Bausch & Lomb, Incorporated | Feb 2, 2009 | APPR |
| P080004 | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS | Hoya Surgical Optics, Inc. | Sep 26, 2008 | APPR |
| P060022 | AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT | Bausch & Lomb, Inc. | Sep 5, 2008 | APPR |
| P060011 | C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) | Rayner Intraocular Lenses , Ltd. | May 3, 2007 | APPR |
| P010027 | ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT) | Aaren Scientific | Nov 21, 2001 | APWD |
| P990080 | CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A | Johnson & Johnson Surgical Vision, Inc. | Apr 5, 2001 | APPR |
| P990013 | COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | Starr Surgical Co. | Apr 2, 2000 | APPR |
| P980040 | SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | Johnson & Johnson Surgical Vision, Inc. | Feb 3, 2000 | APPR |
| P990014 | HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | Bausch & Lomb, Inc. | Nov 12, 1999 | APWD |
| P970034 | MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES | Aaren Scientific | Sep 25, 1998 | APWD |
| P960036 | MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A) | Ioltech, S.A. | Dec 22, 1997 | APWD |
| P940007 | PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL | Advanced Medical Optics, Inc. | Jul 20, 1995 | APWD |
| P930014 | ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES | Alcon Laboratories, Inc. | Dec 22, 1994 | APPR |
| P910061 | MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS | Bausch & Lomb | Sep 2, 1994 | APPR |
| P890056 | MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS | Advanced Medical Optics, Inc. | May 26, 1994 | APWD |
| K914311 | 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
- Alcon — 3 clearances
