Device recall
Z-1272-2018: The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond…
FDA device recall · Class II · SIE AG, Surgical Instrument Engineering
Key facts
| Recall number (Z-number) | Z-1272-2018 |
|---|---|
| Recall event | 79379 |
| Product | The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for… |
| Product code | OOE |
| Recalling firm | SIE AG, Surgical Instrument Engineering |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 2, 2018 |
| 510(k) numbers | K150323 |
| FEI number | 3005643720 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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