Device recall
Z-2855-2016: SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is…
FDA device recall · Class II · Abbott Medical Optics Inc. (AMO)
Key facts
| Recall number (Z-number) | Z-2855-2016 |
|---|---|
| Recall event | 75051 |
| Product | SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. |
| Product code | HQL |
| Recalling firm | Abbott Medical Optics Inc. (AMO) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 23, 2016 |
| PMA numbers | P980040 |
| FEI number | 3003843509 |
At a glance
- None Linked 510(k)s
- 10–99 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