Medical Device Recall: EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Staar Surgical AG · January 21, 2026
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
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
Quantity Affected
7
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1480-2026
Status: ongoing
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