Reported Jun 24, 2026 · Ongoing
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL…
Staar Surgical AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Staar Surgical AG · Haupt Strasse 104 · Nidau · N/A
Is this the product you have?
- Product NameSTAAR ICL
- Calculation Software Software VersionVersion 8.00
- Product DescriptionThe 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
- NoteThe 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
- ComponentNo
- Lot codes and dates
- Lot CodeUDI (01)00840311346288(0812)8.00 Software Version 8.00 The software error occurs if a customer generated an IOD for a toric implantation from April 13, 2026 to April 16, 2026 for multiple toric lens reservations for the same eye using the STAAR ICL Calculation Software
- Amount recalled
- 543
Where it was sold
Why it was recalled
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
This product could cause temporary or reversible health problems — stop using it.
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