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FDA-Device2026-06-24Class IIPROCESSING DEFECT

Staar Surgical ICL Calculation Software Version 8.00 recalled for orientation diagram coding error

Staar Surgical
OTHERNationwide distribution

Staar Surgical ICL Calculation Software recalled for diagram error

Staar Surgical's ICL Calculation Software Version 8.00 contains a coding error that can produce incorrect implantation orientation diagrams for toric intraocular lenses. The error occurs when multiple toric lens calculations are generated for the same eye between April 13–16, 2026. An incorrect diagram could lead to improper lens alignment during surgery.

  • If you used this software to generate orientation diagrams for toric ICL implants between April 13–16, 2026, contact Staar Surgical immediately.
  • Do not proceed with surgery based on a diagram generated during the affected dates without verification.
  • Contact your Staar Surgical representative or visit the company's support portal for corrected diagrams and updated software guidance.
Hazard

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

Sold states
Worldwide - US Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Austria, Australia, Belgium, Canada, Switzerland, Czech Republic, Germany Spain, Finland, France, Great Britain, Hong Kong, Ireland, Israel, India, Iran, Italy, Jordan, Korea, Kuwait, Kazakhstan, Morocco, Malaysia, Netherlands, Oman, Philippines, Poland, Saudi Arabia, Sweden, Singapore, Thailand, Turkey, Taiwan, Ukraine, USA, Vietnam.
Affected count
543
Manufactured in
Haupt Strasse 104, Nidau, Switzerland
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2509-2026

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