Staar Surgical
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Staar Surgical 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
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
- 2026-03-11FDA-DeviceClass IIStop using Staar Surgical EVO+ Visian Toric implants
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
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