Z-2509-2026Class II

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR...

Name: Z-2509-2026 Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR...
Creator: Staar Surgical AG
Published: 2026-04-20
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2026-04-20 / Open, Classified / root cause: software

FDA source

Staar Surgical AG began a recall of Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in... on 2026-04-20. FDA classified it as Class II and gives the reason as "Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2509-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-20
Posted: 2026-06-18
Recalling firm: Staar Surgical AG
Product: 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
Product code: MTA Lens, Intraocular, Phakic
Reason for recall: Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
Root cause tag: software
FDA root cause: Software design
Action: On 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 [email protected] or by phone at 1-800-352-7842 Monday through Friday, 6:00am to 5:00pm PDT.
Quantity in commerce: 543
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2509-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2509-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17

Product code MTA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)