Device recall
Z-0066-2019: OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS…
FDA device recall · Class II · Johnson & Johnson Surgical Vision Inc
Key facts
| Recall number (Z-number) | Z-0066-2019 |
|---|---|
| Recall event | 80849 |
| Product | OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers… |
| Product code | OOE |
| Recalling firm | Johnson & Johnson Surgical Vision Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2021 |
| 510(k) numbers | K113479, K121091, K141079, K170322, K172002 |
| FEI number | 3006695864 |
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