Device recall
Z-1309-2015: Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0…
FDA device recall · Class II · Aaren Scientific, Incorporated
Key facts
| Recall number (Z-number) | Z-1309-2015 |
|---|---|
| Recall event | 70557 |
| Product | Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. 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… |
| Product code | HQL |
| Recalling firm | Aaren Scientific, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 29, 2015 |
| 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