Recall Z-2509-2026— Staar Surgical AG

Class II FDA medical device recall by Staar Surgical AG, initiated 2026-04-20. FDA's recall record names no specific 510(k) clearance for this event. 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: Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses..

Recalling firm

Staar Surgical AG

Classification

Class II

Status

Ongoing

Initiated

2026-04-20

Firm location

Nidau, Switzerland

Data sourced from openFDA. This site is unofficial and independent of the FDA.