Device recall
Z-1695-2008: Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use…
FDA device recall · Class II · VISX INCORPORATED, A SUBSIDIARY OF AMO INC
Key facts
| Recall number (Z-number) | Z-1695-2008 |
|---|---|
| Recall event | 47824 |
| Product | Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target… |
| Product code | LZS |
| Recalling firm | VISX INCORPORATED, A SUBSIDIARY OF AMO INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 8, 2010 |
| PMA numbers | P930016, P930016S023, P930016/S16 |
| FEI number | 1221842 |
At a glance
- None 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