Recall Z-1680-2025— Bausch & Lomb Surgical, Inc.

Name: FDA recall Z-1680-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-27

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 Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.. 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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.