Class II

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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.