MX60ET — Class II medical device recall Z-0519-2021
Terminated recall by Bausch & Lomb Surgical, Inc., reported 2020-12-09, distributed nationwide. Product may be missing toric axis marks.
| Recall number | Z-0519-2021 |
|---|---|
| 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 | 2020-11-07 |
| Classified | 2020-12-02 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2024-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 31 devices |
| Lot numbers | 3043816 |
| Serial numbers | 3043816001, 3043816002, 3043816003, 3043816004, 3043816005, 3043816006, 3043816007, 3043816008, 3043816009, 3043816010, 3043816011, 3043816012, 3043816013, 3043816014, 3043816015, 3043816016, 3043816017, 3043816018, 3043816019, 3043816020, 3043816023, 3043816024, 3043816025, 3043816026, 3043816027 and 4 more |
| Model numbers | MX60ET |
Product
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
Reason for recall
Product may be missing toric axis marks.
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-0519-2021. 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.