Device recall
Z-2292-2011: WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight…
FDA device recall · Class II · Wavelight AG
Key facts
| Recall number (Z-number) | Z-2292-2011 |
|---|---|
| Recall event | 58601 |
| Product | WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating… |
| Product code | HNO |
| Recalling firm | Wavelight AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2011 |
| 510(k) numbers | K101006 |
| FEI number | 3003288808 |
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