Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1680-2025 — Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

U.S. FDA — Device Enforcement · United States · 2025-03-27 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1680-2025
Date of alert
2025-03-27
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Bausch & Lomb Surgical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10757770636478
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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