Intraocular Lens — Class I medical device recall Z-1680-2025
Ongoing recall by Bausch & Lomb Surgical, Inc., reported 2025-05-14, distributed nationwide. In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with im
| Recall number | Z-1680-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb Surgical, Inc., Clearwater, FL, United States |
| Recall initiated | 2025-03-27 |
| Classified | 2025-05-02 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Quantity | 48,237 |
| UPC / GTIN / UDI-DI | 10757770636478, 10757770636485, 10757770636492, 10757770636553, 10757770636560, 10757770636577, 10757770636584, 10757770636591, 10757770636607, 10757770637017, 10757770637031, 10757770637055, 10757770637079, 10757770637093, 10757770637109, 10757770637116, 10757770637123, 10757770637130, 10757770637147, 10757770637154, 10757770637161, 10757770637178, 10757770637185, 10757770637192, 10757770637208 and 475 more |
Product
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1680-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.