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EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Class II
Recalling firm
Staar Surgical AG
Reason for recall
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.
Distribution pattern
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
State
N/A
Status
Ongoing
Recall number
Z-1480-2026
Recall initiated
January 21, 2026
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