Staar Surgical AG recalls EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: V
Recalled Product
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Hazard / Issue
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.
Issued by
FDA
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