Drug recall
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL…
FDA recall event 99007 · Class II · Staar Surgical AG
Key facts
| Event ID | 99007 |
|---|---|
| Recall numbers | Z-2509-2026 |
| Recalling firm | Staar Surgical AG |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses. |
| Initiation date | Apr 20, 2026 |
| Report date | Jun 24, 2026 |
| City | Nidau |
| Country | Switzerland |
| FEI number | 3002808259 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: