Device recall
Z-0591-2010: Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only…
FDA device recall · Class II · Bausch & Lomb Inc
Key facts
| Recall number (Z-number) | Z-0591-2010 |
|---|---|
| Recall event | 53949 |
| Product | Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Manufactured by: Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has… |
| Product code | HQL |
| Recalling firm | Bausch & Lomb Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2010 |
| PMA numbers | P910061 |
| FEI number | 1317628 |
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