Device recall
Z-1984-2013: Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to…
FDA device recall · Class II · Medicel Ag
Key facts
| Recall number (Z-number) | Z-1984-2013 |
|---|---|
| Recall event | 65908 |
| Product | Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer nanoFLEX or Afinity IOLs, through surgical procedure in a human eye. |
| Product code | HQL |
| Recalling firm | Medicel Ag |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 11, 2014 |
| 510(k) numbers | K070669 |
| FEI number | 3006151006 |
At a glance
- 1–9 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