Reported May 14, 2025 · Ongoing
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Bausch & Lomb Surgical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bausch & Lomb Surgical, Inc. · 21 N Park Place Blvd · Clearwater, FL · 33759-3917
Is this the product you have?
- Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
- Lot codes and dates
- Description/Lots/UDI-DI
1,550 of 1,550 codes
enVista Envy IOL (ENU)/3Q247643Q249353Q251133Q258333Q262563Q262573Q265383Q266013Q266033Q266043Q266793Q266803Q273533Q274473Q274573Q279053Q279073Q280013Q280023Q281243Q281253Q288013Q289013Q289033Q289043Q289053Q289063Q290203Q290213Q292053Q292663Q293013Q293023Q293043Q293053Q293063Q294013Q294033Q294053Q294063Q295453Q295473Q295483Q296363Q296373Q298353Q298373Q302103Q303103Q303113Q337023Q338223Q339183Q339213Q339243Q339253Q339283Q340313Q340343Q34205
- Description/Lots/UDI-DI
- Amount recalled
- 48,237
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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 enVista monofocal lenses in the U.S.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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