Device recall
Z-1153-2014: Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl…
FDA device recall · Class II · Carl Zeiss Meditec AG
Key facts
| Recall number (Z-number) | Z-1153-2014 |
|---|---|
| Recall event | 67440 |
| Product | Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the… |
| Product code | HQF |
| Recalling firm | Carl Zeiss Meditec AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2014 |
| 510(k) numbers | K100253 |
| FEI number | 3001362763 |
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