Home › Device types › HQL
Intraocular Lens
FDA product code HQL · Class 3 · Ophthalmic
19,619
Registered devices
75,921
Adverse events
75
Recalls
5
510(k) clearances
Devices with this code
Clareon — Alcon Laboratories, Inc.Alcon Single-Piece PMMA
Slant — Alcon Laboratories, Inc.ACRYSOF® — Alcon Laboratories, Inc.CIRRUS — EYEKON MEDICAL, INC.Multiflex — Alcon Laboratories, Inc.IPure — HOYA MEDICAL SINGAPORE PTE. LTD.MDR — EYEKON MEDICAL, INC.MDR — EYEKON MEDICAL, INC.CLARIFLEX — JOHNSON & JOHNSON SURGICAL VISION, INC.SENSAR IOL — JOHNSON & JOHNSON SURGICAL VISION, INC.ACUITY — EYEKON MEDICAL, INC.ISOTECHNICS — EYEKON MEDICAL, INC.SENSAR IOL — JOHNSON & JOHNSON SURGICAL VISION, INC.SUNCOAST — EYEKON MEDICAL, INC.DGR — EYEKON MEDICAL, INC.SENSAR IOL — JOHNSON & JOHNSON SURGICAL VISION, INC.TECNIS IOL — JOHNSON & JOHNSON SURGICAL VISION, INC.Alcon Single-Piece PMMA
Slant — Alcon Laboratories, Inc.Clareon — Alcon Laboratories, Inc.CIRRUS — EYEKON MEDICAL, INC.EYEKON — EYEKON MEDICAL, INC.ISOTECHNICS — EYEKON MEDICAL, INC.iSert Intraocular Lens — HOYA MEDICAL SINGAPORE PTE. LTD.PURESEE IOL — JOHNSON & JOHNSON SURGICAL VISION, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-19 | AMO Puerto Rico Manufacturing, Inc. | Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistent |
| 2025-06-06 | Bausch & Lomb Surgical, Inc. | An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result |
| 2025-03-27 | Bausch & Lomb Surgical, Inc. | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs |
| 2023-07-06 | Johnson & Johnson Surgical Vision, Inc. | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. |
| 2022-05-13 | Rayner Intraocular Lenses Ltd | The outer package is mislabeled and the package contains a different IOL strength. |
| 2022-05-11 | Alcon Laboratories Ireland, Ltd | Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to impro |
| 2020-06-09 | Bausch & Lomb Surgical, Inc. | The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. |
| 2020-04-17 | Alcon Research LLC | Incorrect IOL diopter |
| 2018-11-09 | Tekia, Inc. | A limited number of lenses may be mislabeled with the incorrect diopter power. |
| 2018-11-05 | Bausch & Lomb Surgical, Inc. | Cosmetic imperfections on the surface of some lenses. |
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