Device recall
Z-0048-2014: STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog…
FDA device recall · Class II · Abbott Medical Optics, Inc.
Key facts
| Recall number (Z-number) | Z-0048-2014 |
|---|---|
| Recall event | 66304 |
| Product | STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive… |
| Product code | LZS |
| Recalling firm | Abbott Medical Optics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 12, 2014 |
| PMA numbers | P930016, P930016S016 |
| 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