Recall Z-2509-2026 ยท MTA Lens, Intraocular, Phakic
Staar Surgical AG
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
| Date | Jun 18, 2026 (initiated Apr 20, 2026) |
| Status | Open, Classified |
| Reason | Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses. |
| 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 iden |
| Quantity | 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, Aus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.