Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Reported: May 14, 2025 Initiated: March 27, 2025 #Z-1680-2025
Product Description
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Reason for Recall
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.
Details
- Recalling Firm
- Bausch & Lomb Surgical, Inc.
- Units Affected
- 48,237
- Distribution
- Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.
- Location
- Clearwater, FL
Frequently Asked Questions
What product was recalled? ▼
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.. Recalled by Bausch & Lomb Surgical, Inc.. Units affected: 48,237.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2025. Severity: Critical. Recall number: Z-1680-2025.
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