Device recall
Z-2282-2014: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated…
FDA device recall · Class II · AMO Puerto Rico Manufacturing, Inc.
Key facts
| Recall number (Z-number) | Z-2282-2014 |
|---|---|
| Recall event | 68346 |
| Product | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 20.5-21 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design… |
| Product code | HQL |
| Recalling firm | AMO Puerto Rico Manufacturing, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2017 |
| PMA numbers | P880081 |
| FEI number | 2648035 |
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