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.
Cleared Devices (65)
| 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 |
| P910058 | CHIROFLEX MODELS 32 C10XX SILICONE POSTERIOR IOL | Bausch & Lomb, Inc. | Jan 17, 1992 | APWD |
| P910056 | SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS | Bausch & Lomb, Inc. | Jan 17, 1992 | APPR |
| K913626 | SOFTRANS INJECTOR | Staar Surgical Co. | Dec 18, 1991 | SESE |
| P880091 | ELASTIC UVA PC IOL. | Staar Surgical Co. | Sep 16, 1991 | APPR |
| P880085 | MODEL 405 SPANFLEX TM IOL | Advanced Medical Optics, Inc. | Jun 27, 1991 | APWD |
| P900053 | MODELS A21-A & A21-B POSTERIOR CHAMBER INTRAOCULAR | Vision Technologies Intl., Inc. | Feb 28, 1991 | APPR |
| P900037 | MODIFIED J&C LOOP POST. CHAMBER INTRAOCULAR LENS | Medical Development Research, Inc. | Feb 28, 1991 | APPR |
| P880082 | MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES | Eyetech, LLC | Jun 13, 1990 | APPR |
| P880087 | KELMAN MULTIFLEX 2 MODELS: MT3-MT7 & MT2U-MT7U | Alcon Laboratories | Jan 31, 1990 | APPR |
| P870045 | SK15 AND SK16 | Bausch & Lomb, Inc. | Jan 24, 1990 | APWD |
| P890068 | MODEL P-11 MODIFIED J-LOOP POSTERIOR CHAMBER IOL | Chiron Ophthalmics | Jan 11, 1990 | APPR |
| P880090 | MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS | Bausch & Lomb, Inc. | Dec 28, 1989 | APPR |
| P880081 | UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES | Johnson & Johnson Surgical Vision, Inc. | Oct 31, 1989 | APPR |
| P860034 | MODEL AC-21 OMNIFIT ANTERIOR CHAMBER | Advanced Medical Optics, Inc. | Sep 29, 1989 | APWD |
| P880072 | MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL | Eyekon Medical, Inc. | Sep 22, 1989 | APPR |
| P880070 | MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS | Abbott Medical Optics, Inc. | Sep 20, 1989 | APWD |
| P870073 | STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES | Bausch & Lomb, Inc. | Mar 31, 1989 | APWD |
| P880010 | INTRAOCULAR LENS MODELS C118;C119;C138 AND C139 | Alcon Laboratories | Oct 5, 1988 | APWD |
| P870013 | IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR | Bausch & Lomb | Mar 31, 1988 | APWD |
| P860059 | MODEL 304 (ULTRA C-LOOP) | Advanced Medical Optics, Inc. | Feb 12, 1988 | APWD |
| P860002 | INTRAOCULAR LENS | Bausch & Lomb | Oct 31, 1986 | APWD |
| P850059 | KELMAN(TM) OMNIFIT II MODEL 2100 | Bausch & Lomb Surgical, Inc. | Jul 31, 1986 | APWD |
| P840060 | SM-1, CR-1, & GR-1 IOLS | Alcon Laboratories | Apr 30, 1986 | APPR |
| P840039 | ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES | Bausch & Lomb, Inc. | Mar 28, 1986 | APPR |
| P830056 | STYLES 31-34 POSTERIOR IOLS | Carl Zeiss Meditec, AG | Mar 28, 1986 | APWD |
| P820035 | OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5) | Alcon | Feb 28, 1986 | APWD |
| P820044 | MODEL 91-50 IOL | Bausch & Lomb, Inc. | Dec 27, 1985 | APWD |
| P830040 | STYLES 30 & 31 POSTERIOR CHAMBER IOLS | Alcon Research, Ltd. | Sep 5, 1985 | APWD |
| P830033 | STYLE 17 & 17A POSTERIOR CHAMBER IOLS | Advanced Vision Science | Sep 5, 1985 | APWD |
| K842892 | NIDEK DIGITAL KERATOMETER | Nidek, Inc. | Oct 5, 1984 | SESE |
| K842504 | AMER. MEDICAL OPTICS DIGITAL KERATO- | American Medical Optics | Oct 1, 1984 | SESE |
| P810056 | MODEL AC10 & AC20 IOLS | Advanced Medical Optics, Inc. | Jul 26, 1983 | APWD |
| P820072 | CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC | Bausch & Lomb, Inc. | Jul 21, 1983 | APWD |
| P820049 | MODELS PC10 & PC21 | Advanced Medical Optics, Inc. | May 17, 1983 | APWD |
| P800049 | MODELS 1S & 1P | Alcon | Mar 31, 1983 | APWD |
| P810001 | MODEL AC (AC1-AC5) | Alcon | Mar 17, 1983 | APWD |
| P810055 | MODELS 019B, 019C, 019E, 019F, 019J, & 019K | Advanced Medical Optics, Inc. | Feb 3, 1983 | APWD |
| P810042 | MODELS 011 & 011B IRIDOCAPSULAR IOLS | Pharmacia, Inc. | Dec 15, 1982 | APPR |
| P800027 | BINKHORST & FEDOROV I IRIS CLIP IOLS | Storz Ophthalmics, Inc. | Jul 26, 1982 | APWD |
| P810018 | POSTERIOR CHAMBER INTRAOCULAR LENSES | Alcon Laboratories | Jul 16, 1982 | APWD |
| P810032 | MODELS B-13F (P-10) & B-1H (P-11) | Alcon Laboratories | Apr 23, 1982 | APPR |
| P800016 | TENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb, Inc. | Mar 26, 1982 | APWD |
| P790027 | CHAMBER LENS MODELS 101, 101B, 101T | Bausch & Lomb | Mar 2, 1982 | APWD |
| P800017 | CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS | Storz Ophthalmics, Inc. | Dec 1, 1981 | APWD |
| K771933 | CILCO ANTERIOR CHAMBER LENS | California Intraocular Lens | Jan 26, 1978 | 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
