enVista one-piece hydrophobic acrylic toric intraocular lens — Class II medical device recall Z-2552-2020
Terminated recall by Bausch & Lomb Surgical, Inc., reported 2020-07-22, distributed nationwide. The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted l
| Recall number | Z-2552-2020 |
|---|---|
| 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 | 2020-06-09 |
| Classified | 2020-07-10 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2021-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| UPC / GTIN / UDI-DI | 10757770555199 |
| Lot numbers | 3043212 |
| Serial numbers | 3043212002 |
| Model numbers | MX60ET |
Product
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.
Reason for recall
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
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-2552-2020. 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.