Device recall
Z-0929-2013: AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with…
FDA device recall · Class II · Abbott Medical Optics Inc (AMO)
Key facts
| Recall number (Z-number) | Z-0929-2013 |
|---|---|
| Recall event | 64015 |
| Product | AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction. |
| 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