HQLFDA Class 3 · 21 CFR 886.3600 · implantable
Intraocular Lens
Device family · Ophthalmic
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
1,672
Manufacturers
34
Flagged signals
13
Adverse-event reports
49,167
Code matrix
| FDA product code | HQL |
| Device class | Class 3 |
| Regulation | 21 CFR 886.3600 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 3 | 48.7 | 97 |
| Other | 2010 | 10 | 42.4 | 364 |
| Other | 2014 | 49 | 19.5 | 842 |
| Other | 2009 | 4 | 16.9 | 45 |
| Other | 2010 | 281 | 15.0 | 3,618 |
| Other | 2011 | 237 | 12.6 | 2,503 |
| Other | 2013 | 29 | 11.5 | 269 |
| Other | 2012 | 18 | 7.2 | 89 |
| Other | 2010 | 68 | 3.6 | 125 |
| Other | 2010 | 17 | 2.9 | 20 |
| Injury | 2010 | 8 | 2.6 | 10 |
| Injury | 2020 | 26 | 2.3 | 28 |
| Other | 2009 | 13 | 2.2 | 8 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 49,167 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Bausch & Lomb, Inc. | 261 | 2025 | — |
| JOHNSON & JOHNSON SURGICAL VISION, INC. | 243 | 2026 | — |
| Advanced Medical Optics, Inc. | 208 | 2008 | — |
| Alcon Laboratories | 177 | 2024 | — |
| Alcon Laboratories, Inc. | 156 | 2026 | — |
| Bausch & Lomb | 110 | 2022 | — |
| Carl Zeiss Meditec, AG | 57 | 1999 | — |
| Hoya Surgical Optics, Inc. | 46 | 2023 | — |
| Lenstec, Inc. | 43 | 2026 | — |
| Alcon Laboratories, LLC | 41 | 2026 | — |
| Starr Surgical Co. | 39 | 2021 | — |
| Rayner Intraocular Lenses , Ltd. | 38 | 2026 | — |
| Staar Surgical Co. | 32 | 2010 | — |
| EYEKON MEDICAL, INC. | 32 | 2000 | — |
| Alcon | 28 | 1998 | — |
| Advanced Vision Science | 24 | 1996 | — |
| Bausch & Lomb Surgical, Inc. | 21 | 2003 | — |
| CARL ZEISS MEDITEC PRODUCTION, LLC | 21 | 2026 | — |
| Aaren Scientific | 21 | 2012 | — |
| Alcon Research, Ltd. | 20 | 2018 | — |
| Eyetech, LLC | 13 | 1995 | — |
| Abbott Medical Optics, Inc. | 12 | 2007 | — |
| Ioltech, S.A. | 8 | 2002 | — |
| Storz Ophthalmics, Inc. | 5 | 1988 | — |
| Newlensco | 3 | 1991 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM · Lenstec, Inc.PMA · 2026-04-15
CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P · Carl Zeiss Meditec Production, LLCPMA · 2026-03-20
CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P · Carl Zeiss Meditec Production, LLCPMA · 2026-03-18
TECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375 · Johnson & Johnson Surgical Vision, Inc.PMA · 2026-03-11
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems · Alcon Laboratories, Inc.PMA · 2026-03-02
Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon® PanOptix Hydrophobic Acrylic IOL · Alcon Laboratories, LLCPMA · 2026-03-02
Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic · Alcon Laboratories, LLCPMA · 2026-02-19
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems · Alcon Laboratories, Inc.PMA · 2026-02-11
Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1 · Rayner Intraocular Lenses , Ltd.PMA · 2026-01-20
SENSAR 1-piece IOL, AAB00; SENSAR Soft Acrylic Posterior Chamber IOL, Models AR40e, AR40E, and AR40M; TECNIS 1-Piece I · Johnson & Johnson Surgical Vision, Inc.PMA · 2026-01-12
TECNIS Foldable Acrylic IOL with OptiEdge, 13.0 mm, ZA9003 · Johnson & Johnson Surgical Vision, Inc.PMA · 2026-01-12
C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) · Rayner Intraocular Lenses , Ltd.PMA · 2025-12-23
TECNIS SIMPLICITY Delivery System · Johnson & Johnson Surgical Vision, Inc.PMA · 2025-12-16
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL · Alcon Laboratories, LLCPMA · 2025-12-12
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems · Alcon Laboratories, Inc.PMA · 2025-12-12
Softec HD; Softec I; Softec HDO; Softec HDM · Lenstec, Inc.PMA · 2025-12-04
TECNIS Symfony Toric II OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System, Models DXW150-375; · Johnson & Johnson Surgical Vision, Inc.PMA · 2025-10-24
RayOne EMV Toric · Rayner Intraocular Lenses , Ltd.PMA · 2025-10-09
Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric, RayOne Aspheric RAO600C, RayOne Spheric RAO100C and RayOne EMV · Rayner Intraocular Lenses , Ltd.PMA · 2025-10-01
Akreos Posterior Chamber Intraocular Lens · Bausch & Lomb, Inc.PMA · 2025-09-30
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems · Alcon Laboratories, Inc.PMA · 2025-09-18
Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le · Alcon Laboratories, LLCPMA · 2025-09-18
TECNIS Foldable Acrylic IOL with OptiEdge · Johnson & Johnson Surgical Vision, Inc.PMA · 2025-09-10
FINEVISION HP Trifocal IOLs · Beaver Visitec International, Inc.PMA · 2025-09-10
SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS · Johnson & Johnson Surgical Vision, Inc.PMA · 2025-09-10
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.