Device recall
Z-0519-2021: MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric…
FDA device recall · Class II · Bausch & Lomb Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-0519-2021 |
|---|---|
| Recall event | 86721 |
| 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. |
| Product code | MJP |
| Recalling firm | Bausch & Lomb Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2024 |
| PMA numbers | P910056, P910056S036 |
| FEI number | 1119279 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database