Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Intraocular Lens. enVista Envy IOL Recalled by Bausch & Lomb Surgical, Inc. Due to In response to an increased number of reports...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bausch & Lomb Surgical, Inc. directly.
Affected Products
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Quantity: 48,237
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bausch & Lomb Surgical, Inc.
Bausch & Lomb Surgical, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report