Device recall
Z-1077-2012: Precision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number…
FDA device recall · Class III · Aaren Scientific, Incorporated
Key facts
| Recall number (Z-number) | Z-1077-2012 |
|---|---|
| Recall event | 60962 |
| Product | Precision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number: 1169381106, 1169391106, 1169421106 The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. |
| Product code | HQL |
| Recalling firm | Aaren Scientific, Incorporated |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 10, 2012 |
| PMA numbers | P100016 |
| FEI number | 3013202565 |
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