Device recall
Z-1311-06: TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614…
FDA device recall · Class II · Tekia Inc
Key facts
| Recall number (Z-number) | Z-1311-06 |
|---|---|
| Recall event | 35817 |
| Product | TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL) |
| Product code | HQL |
| Recalling firm | Tekia Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2012 |
| FEI number | 3002023310 |
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