Device recall
Z-1746-2013: nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or…
FDA device recall · Class II · Staar Surgical Co.
Key facts
| Recall number (Z-number) | Z-1746-2013 |
|---|---|
| Recall event | 65558 |
| Product | nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis. |
| Product code | HQL |
| Recalling firm | Staar Surgical Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 17, 2013 |
| PMA numbers | P990013 |
| FEI number | 2023826 |
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