Staar Surgical Company recalls
13 federal recalls on file, showing the 2 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Staar Surgical Company and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-06-24FDA-DeviceClass IIStaar Surgical ICL Calculation Software recalled for diagram error
Staar Surgical's ICL Calculation Software Version 8.00 contains a coding error that can produce incorrect implantation orientation diagrams for toric intraocular lenses. The error occurs when multiple toric lens calculations are generated for the same eye between April 13–16, 2026. An incorrect diagram could lead to improper lens alignment during surgery.
- 2026-03-11FDA-DeviceClass IIStop using Staar Surgical EVO+ Visian Toric implants
Staar Surgical EVO+ Visian Toric Implantable Collamer Lenses (Model VTICM5) were labeled as 12.1 mm but are actually 12.6 mm in length. The larger size can cause the lens to sit too high in the eye, potentially reducing eye drainage and increasing eye pressure, which may lead to discomfort, vision problems, or the need for lens removal.
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