Device recall
Z-2970-2011: STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by: AMO…
FDA device recall · Class II · AMO Manufacturing USA, LLC
Key facts
| Recall number (Z-number) | Z-2970-2011 |
|---|---|
| Recall event | 59330 |
| Product | STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different… |
| Product code | LZS |
| Recalling firm | AMO Manufacturing USA, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2013 |
| PMA numbers | P930016, P930016S019 |
| FEI number | 3006695864 |
At a glance
- None Linked 510(k)s
- 10–99 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