Recall Z-1679-2025— Bausch & Lomb Surgical, Inc.
Class I · Ongoing
Class I FDA medical device recall by Bausch & Lomb Surgical, Inc., initiated 2025-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;. Reason: 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..
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-03-27
- Firm location
- Clearwater, FL, United States
Product description
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.