Z-2509-2026 Class II Ongoing
FDA device recall Z-2509-2026 was initiated by Staar Surgical AG on April 20, 2026 and is designated Class II. Reason for recall: Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses. The recall status is ongoing. Affected quantity: 543.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2026
- Initiation Date
- April 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 543
Product Description
Reason for Recall
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.