[pending] Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All model
Pending LLM rewrite. Source: FDA_DEVICE Z-1679-2025.
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 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;
- 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 Monofocal IOL (EEU)/3Q25120
- 3Q25326
- 3Q25327
- 3Q25347
- 3Q25348
- 3Q25425
- 3Q25426
- 3Q25427
- 3Q25507
- 3Q25508
- 3Q25509
- 3Q25510
- 3Q25511
- 3Q25548
- 3Q25549
- 3Q25550
- 3Q25628
- 3Q25632
- 3Q25730
- 3Q25731
Distribution
Distributed nationwide across the United States.
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