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enVista Envy™ Toric IOL

Bausch & Lomb Incorporated · Model ETN · UDI-DI 10757770640208

MFK Prescription
0
510(k) clearances
12,970
Adverse events
4
Recalls
18
Facilities

Description

enVista Envy toric hydrophobic acrylic IOL (non-preloaded) +16.50D SE / +1.25D CYL

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.