Device recall
Z-0358-2016: IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is…
FDA device recall · Class II · Carl Zeiss Meditec AG
Key facts
| Recall number (Z-number) | Z-0358-2016 |
|---|---|
| Recall event | 72564 |
| Product | IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the… |
| 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