BEUDAMED
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    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

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical AG·June 24, 2026

    EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical AG·March 11, 2026