Device recall
Z-0811-2014: 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser…
FDA device recall · Class II · Ziemer Usa Inc
Key facts
| Recall number (Z-number) | Z-0811-2014 |
|---|---|
| Recall event | 64966 |
| Product | 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV… |
| Product code | HQF |
| Recalling firm | Ziemer Usa Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2017 |
| 510(k) numbers | K112154 |
| FEI number | 3006231532 |
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