Product Name: STAAR ICL Calculation Software Software Version:… — Class II medical device recall Z-2509-2026
Ongoing recall by Staar Surgical AG, reported 2026-06-24, distributed nationwide. Due to a software coding issues for calculating the implant orientation diagram printout for the implantation
| Recall number | Z-2509-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Staar Surgical AG, Nidau, Switzerland |
| Recall initiated | 2026-04-20 |
| Classified | 2026-06-17 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, ES, FI, FR, GB, HK, IE, IL, IN, IR, IT, JO, KR, KW, MA, MY, NL, OM, PH, PL, SA, SE, SG, TH, TR, TW, UA, VN |
| Quantity | 543 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00840311346288 |
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 Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No
Reason for recall
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2509-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.