FDA Device recall Z-0519-2021
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placeme…
- FDA Device
- Class II
- terminated
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placeme… by Bausch And Lomb Surgical, citing product may be missing toric axis marks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0519-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-07 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bausch And Lomb Surgical |
| Distribution | US |
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
Product may be missing toric axis marks.
Identifiers
| code_info | Lot number: 3043816 Serial numbers: 3043816001 3043816002 3043816003 3043816004 3043816005…Lot number: 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 3043816028 3043816029 3043816030 3043816031 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0519-2021%22
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