Device recall
Z-0680-2020: VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE)…
FDA device recall · Class II · Carl Zeiss Meditec, Inc.
Key facts
| Recall number (Z-number) | Z-0680-2020 |
|---|---|
| Recall event | 83913 |
| Product | VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed… |
| Product code | OTL |
| Recalling firm | Carl Zeiss Meditec, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2021 |
| PMA numbers | P150040 |
| FEI number | 2918630 |
At a glance
- None 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