Device recall
Z-2154-2015: Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The…
FDA device recall · Class II · Bausch & Lomb Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-2154-2015 |
|---|---|
| Recall event | 71411 |
| Product | Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients. |
| Product code | HQL |
| Recalling firm | Bausch & Lomb Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 25, 2016 |
| PMA numbers | P910061 |
| 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