Device recall
Z-0334-2014: Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered…
FDA device recall · Class II · Carl Zeiss Meditec, Inc.
Key facts
| Recall number (Z-number) | Z-0334-2014 |
|---|---|
| Recall event | 66635 |
| Product | Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and… |
| Product code | HJO |
| Recalling firm | Carl Zeiss Meditec, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2014 |
| 510(k) numbers | K101182, K122418, K993357 |
| FEI number | 2918630 |
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