Device recall
Z-1597-2016: INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718…
FDA device recall · Class II · Alcon Research, Ltd.
Key facts
| Recall number (Z-number) | Z-1597-2016 |
|---|---|
| Recall event | 73767 |
| Product | INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts. |
| Product code | HQC |
| Recalling firm | Alcon Research, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2017 |
| 510(k) numbers | K021566 |
| FEI number | 1610287 |
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