STAAR ICL Calculation Software
Staar Surgical is recalling Version 8.00 of its ICL Calculation Software due to a coding error affecting toric lens orientation diagrams.
Physicians and clinical staff should immediately discontinue use of the Version 8.00 software for toric ICL planning and contact Staar Surgical for updated software instructions.
Why it was recalled
Staar Surgical is recalling Version 8.00 of the STAAR ICL Calculation Software due to a coding error that may result in an incorrect Implantation Orientation Diagram (IOD) for toric implantable collamer lenses. This software is used by physicians to calculate lens size and power, and the defect specifically affects the pictorial representation of the axis of rotation and alignment.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| 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 | 00840311346288 | Z-2509-2026 |
| 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 | – | – |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Staar Surgical AG
Editorial summary by Recall Canary · last updated 2026-06-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification