- Recalling firm
- Staar Surgical AG
- Reason for recall
- Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 543
- Distribution pattern
- 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.
- Firm location
- Nidau, Switzerland
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2509-2026
- Recall initiated
- April 20, 2026
- FDA classification date
- June 17, 2026
- FDA report date
- June 24, 2026
- FDA event ID
- 99007
- Last updated on HTM Vibe
- July 23, 2026