Device recall
Z-0357-2016: IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular…
FDA device recall · Class II · Carl Zeiss Meditec AG
Key facts
| Recall number (Z-number) | Z-0357-2016 |
|---|---|
| Recall event | 72564 |
| Product | IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation. |
| Product code | HJO |
| Recalling firm | Carl Zeiss Meditec AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 2016 |
| 510(k) numbers | K101182, K122418, K993357 |
| FEI number | 3001362763 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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