Device recall
Z-0276-2012: Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar…
FDA device recall · Class II · Abbott Medical Optics Inc (AMO)
Key facts
| Recall number (Z-number) | Z-0276-2012 |
|---|---|
| Recall event | 59980 |
| Product | Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by… |
| Product code | HQL |
| Recalling firm | Abbott Medical Optics Inc (AMO) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 8, 2014 |
| PMA numbers | P980040 |
| FEI number | 3003843509 |
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