Device recall
Z-1679-2025: Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista…
FDA device recall · Class I · Bausch & Lomb Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1679-2025 |
|---|---|
| Recall event | 96594 |
| Product | Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA; |
| Product code | HQL |
| Recalling firm | Bausch & Lomb Surgical, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P910056, P910056S051 |
| FEI number | 1119279 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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