Device recall
Z-0628-2019: enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for…
FDA device recall · Class II · Bausch & Lomb Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-0628-2019 |
|---|---|
| Recall event | 81600 |
| Product | enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag. |
| Product code | HQL |
| Recalling firm | Bausch & Lomb Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2019 |
| PMA numbers | P910056 |
| 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