Staar Surgical recalls software version 8.00 for ICL calculations due to errors in implant orientation diagrams for toric lenses. Affected users may need to update software to avoid incorrect lens placement.
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
Staar Surgical is recalling its ICL calculation software version 8.00 because it can produce incorrect implant orientation diagrams for toric lenses. This could lead to improper lens placement during surgery. The recall affects users who generated orientation diagrams between April 13 and April 16, 2026.
The software has a coding issue that causes incorrect implant orientation diagrams when generating multiple toric lens reservations for the same eye within a specific date window. This could lead to improper lens placement during surgery if the diagrams are used without correction.
Physicians using the STAAR ICL Calculation Software version 8.00 to plan toric lens implants are affected. Those who generated implant orientation diagrams for multiple toric lens reservations for the same eye between April 13 and April 16, 2026, are most at risk.
Check if you have the software version 8.00 installed on your system. Look for the specific date range: April 13 to April 16, 2026, when generating implant orientation diagrams for multiple toric lens reservations for the same eye.
Download and install the corrected software version from the official STAAR Surgical website to avoid incorrect implant orientation diagrams.
The software has a coding issue that can produce incorrect implant orientation diagrams for toric lenses, but it does not cause immediate harm. Physicians should update to the corrected version to prevent potential errors.
You have the affected software if you used version 8.00 to generate implant orientation diagrams for multiple toric lens reservations for the same eye between April 13 and April 16, 2026.
Update to the corrected software version from the official STAAR Surgical website to ensure accurate implant orientation diagrams.
We’ve drafted a message you can send Staar Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2509-2026 — Staar Surgical Staar Surgical Hello, I own a Staar Surgical that is covered by recall Z-2509-2026 from Staar Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
