Device recall
Z-2509-2026: Product Name: STAAR ICL Calculation Software Software Version: Version 8.00…
FDA device recall · Class II · Staar Surgical AG
Key facts
| Recall number (Z-number) | Z-2509-2026 |
|---|---|
| Recall event | 99007 |
| Product | Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation… |
| Product code | MTA |
| Recalling firm | Staar Surgical AG |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P030016, P030016S027 |
| FEI number | 3002808259 |
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