Device recall
Z-2310-2008: AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The…
FDA device recall · Class II · VISX INCORPORATED, A SUBSIDIARY OF AMO INC
Key facts
| Recall number (Z-number) | Z-2310-2008 |
|---|---|
| Recall event | 48736 |
| Product | AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations… |
| Product code | LZS |
| Recalling firm | VISX INCORPORATED, A SUBSIDIARY OF AMO INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2011 |
| PMA numbers | P930016, P930016/R012, P930016S016 |
| 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