Device recall
Z-1541-2013: STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510…
FDA device recall · Class II · Abbott Medical Optics, Inc.
Key facts
| Recall number (Z-number) | Z-1541-2013 |
|---|---|
| Recall event | 65285 |
| Product | STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. |
| Product code | LZS |
| Recalling firm | Abbott Medical Optics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 12, 2014 |
| PMA numbers | P930016, P930016S019 |
| FEI number | 3006695864 |
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