Device recall
Z-1702-2008: Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification…
FDA device recall · Class II · Advanced Medical Optics, Inc.
Key facts
| Recall number (Z-number) | Z-1702-2008 |
|---|---|
| Recall event | 47908 |
| Product | Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. |
| Product code | HQC |
| Recalling firm | Advanced Medical Optics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 21, 2010 |
| 510(k) numbers | K060366 |
| FEI number | 3003843509 |
At a glance
- 1–9 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