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

FDA device recall Z-2509-2026 · posted 2026-06-18 · Open, Classified

Recall details

Recalling firm

Staar Surgical AG

Reason for recall

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

Action taken

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 customerservice@staar.com or by phone at 1-800-352-7842 Monday through Friday, 6:00am to 5:00pm PDT.

Root cause

Software design

Status

Open, Classified

Product code

MTA

Quantity affected

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,

Date initiated

2026-04-20

Date posted

2026-06-18

Location

Nidau, Switzerland