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iSymm Intraocular Lens
HOYA MEDICAL SINGAPORE PTE. LTD. · Model FC-60AD (clear), +12.50D · UDI-DI 04547480103891
HQL
Prescription
5
510(k) clearances
75,921
Adverse events (4 deaths)
75
Recalls
57
Facilities
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 consistently as expected. |
| 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 in functional visua |
| 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, and certain enVist |
| 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 improper manufacturing li |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.