enVista One Piece Hydrophobic Acrylic Intraocular lens — Class II medical device recall Z-0628-2019
Terminated recall by Bausch & Lomb Surgical, Inc., reported 2018-12-26, distributed nationwide. Cosmetic imperfections on the surface of some lenses.
| Recall number | Z-0628-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb Surgical, Inc., Clearwater, FL, United States |
| Recall initiated | 2018-11-05 |
| Classified | 2018-12-18 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2019-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 70,440 units |
| Model numbers | MX60E |
Product
enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.
Reason for recall
Cosmetic imperfections on the surface of some lenses.
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-0628-2019. 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.