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 83)
Showing 20 most recent of 83 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P980040S176 | TECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375 | Johnson & Johnson Surgical Vision, Inc. | Mar 11, 2026 | APPR |
| P060011S039 | RayOne EMV Toric | Rayner Intraocular Lenses , Ltd. | Oct 9, 2025 | APPR |
| 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 |
| P930014S045 | ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL | Alcon Laboratories, Inc. | May 3, 2011 | 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 |
| P930014S015 | ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS MODELS SA60T3, SA60T4 AND SA60T5 | Alcon Laboratories, Inc. | Sep 14, 2005 | 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 |
| P970034S004 | POSTERIOR CHAMBER INTRAOCULAR LENSES | Aaren Scientific | Apr 28, 2000 | 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 |
Top Applicants
- Bausch & Lomb, Inc. — 13 clearances
- Advanced Medical Optics, Inc. — 10 clearances
- Alcon Laboratories — 7 clearances
- Bausch & Lomb — 6 clearances
- Johnson & Johnson Surgical Vision, Inc. — 4 clearances
