Staar Surgical Ag: Lens, Intraocular, Phakic

Recall Summary STAAR Surgical's ICL Calculation Software (Version 8.00), used by eye doctors to plan implantable lens procedures, is being recalled due to a coding error that produces incorrect implant orientation diagrams for toric (astigmatism-correcting) lenses. The software is available on STAAR's website as part of their Stella planning support tool and has been distributed worldwide, including throughout the United States and multiple international countries. This is classified as a Class III recall, the least serious classification.

Recalling firm: Staar Surgical AG
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...
Reason: Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
Classification: Class III
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-04-20
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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,...

Recall details on Nibble Recalls: https://trynibble.app/recalls/01b8684c-7a32-40c4-91ae-e8b476824e77