Staar Surgical AG: 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

Hazard

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

Details from the source

Reason for recall: Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses. Distribution: 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, Quantity: 543 Lot/code info: Lot Code: UDI (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.

UPC codes

00840311346288

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.