Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calcula
Summary
The FDA issued a Class II for Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Pr by Staar Surgical AG. Reason: Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses..
Details
Source
Device Recall
External ID
Z-2509-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
Product Description
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 recall communication. Component: No
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.
Quantity Affected: 543
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, 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-20
Company
Nidau
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Staar Surgical AG has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Staar Surgical AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Staar Surgical AG have FDA actions?
Staar Surgical AG has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2509-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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