[pending] Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models
Pending LLM rewrite. Source: FDA_DEVICE Z-1680-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
- Manufacturer
- Bausch & Lomb Surgical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Description/Lots/UDI-DI: enVista Envy IOL (ENU)/3Q24764
- 3Q24935
- 3Q25113
- 3Q25833
- 3Q26256
- 3Q26257
- 3Q26538
- 3Q26601
- 3Q26603
- 3Q26604
- 3Q26679
- 3Q26680
- 3Q27353
- 3Q27447
- 3Q27457
- 3Q27905
- 3Q27907
- 3Q28001
- 3Q28002
- 3Q28124
Distribution
Distributed nationwide across the United States.
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