Device recall
Z-1680-2025: Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy…
FDA device recall · Class I · Bausch & Lomb Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1680-2025 |
|---|---|
| Recall event | 96594 |
| Product | Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN. |
| Product code | MFK |
| Recalling firm | Bausch & Lomb Surgical, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P240005 |
| 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