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U.S. Department of Health and Human Services

Class 2 Device Recall STAAR ICL Calculation Software Version 8.00

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 Class 2 Device Recall STAAR ICL Calculation Software Version 8.00see related information
Date Initiated by FirmApril 20, 2026
Date PostedJune 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2509-2026
Recall Event ID 99007
PMA NumberP030016S027 
Product Classification Lens, intraocular, phakic - Product Code MTA
ProductProduct 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
Code Information 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.
FEI Number 3002808259
Recalling Firm/
Manufacturer		 Staar Surgical AG
Haupt Strasse 104
Nidau Switzerland
For Additional Information ContactPhilip Tsung
626-3037902 Ext. 2263
Manufacturer Reason
for Recall		Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
FDA Determined
Cause 2		Software design
ActionOn 04/20/2026, the firm sent via FedEx an "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that STAAR has confirmed that during that period, the printing of the IOD within the Stella Patient View, Order Confirmation, or Shopping Cart, when performed locally (i.e. by doctor/clinic), was under certain circumstances producing an incorrect diagram. The incorrect diagram was produced in certain circumstances when users created multiple Toric lens line items with different axis values on the same patient eye, such as with backup or secondary lens reservations. The root cause has been identified as a software coding error in Stella 2.0 that did not assign a unique identifier to each reservation under a patient s eye. STAAR has modified the software code to assign a unique identifier, thereby preventing this issue when multiple reservations exist. Any IOD printed from Stella 2.0 after 5:30pm PDT on April 16, 2026 would not have been affected by this issue. For Customer's awareness: We are informing you so that a proper clinical decision can be made regarding patient management and follow-up, based on your assessment of the clinical outcome. Please immediately complete and return the Recall Response Form acknowledging receipt of this recall and report any adverse events associated with this event. If a Toric EVO/EVO+ device were implanted using an incorrect IOD printout, there is the potential for the following adverse events: " Refractive surprise " Blurred vision " Glares/Halos " Other visual disturbances Repositioning or removal of the lens may need to be considered in these cases. For Questions - contact STAAR Sales Representative or Customer Service at customerservice@staar.com or by phone at 1-800-352-7842 Monday through Friday, 6:00am to 5:00pm PDT.
Quantity in Commerce543
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MTA
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