FDA recall, , Moderate risk
STAAR ICL Calculation Software
The STAAR ICL Calculation Software has a coding issue that affects the implant orientation diagram printout.
Summary by Recall Canary from the FDA notice
What happened
Staar Surgical AG of Nidau, Switzerland, began a recall of its STAAR ICL Calculation Software, Version 8.00, on April 20, 2026, due to software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
The FDA classified the recall on June 17, 2026, and added it to the Enforcement Report on June 18, 2026, with the weekly report on June 24, 2026. The software is designed as an aide in calculating lens size and diopter power, and for toric ICLs, it produces an Implantation Orientation Diagram (IOD) to provide a pictorial representation of the axis of rotation and alignment.
The recall affects distribution nationwide in the U.S., including states and Puerto Rico, and worldwide in numerous countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Staar ICL Calculation Software
- UDI-DI
- 00840311346288
- Software version
- Version 8.00
Recall details
- Company began the recall
- Sold in
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.
- Company
- Staar Surgical AGNidau, Switzerland
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99007
- Recall number
- Z-2509-2026
All recalls from Staar Surgical AG
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated