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enVista Envy™ IOL

Bausch & Lomb Incorporated · Model EN · UDI-DI 10757770637482

MFK Prescription
0
510(k) clearances
12,997
Adverse events
4
Recalls
18
Facilities

Description

enVista Envy hydrophobic acrylic IOL (non-preloaded) +31.50D

Recalls

DateFirmReason
2025-03-27Bausch & 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
2006-12-14Alcon Laboratories, IncIntraocular lenses exposed to extreme temperatures while in storage.
2006-12-14Alcon Laboratories, IncIntraocular lenses exposed to extreme temperatures while in storage.
2006-12-14Alcon Laboratories, IncIntraocular lenses exposed to extreme temperatures while in storage.

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Data 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.