FDA recall Z-1679-2025

Bausch & Lomb Surgical, Inc. · Class I · device

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 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.

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.

Key facts

Status
Ongoing
Initiation date
2025-03-27
Report date
2025-05-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Clearwater, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1679-2025