Staar Surgical AG recalls EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Recall date

January 21, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1480-2026

FDA classification

Class II

Brand / firm

Staar Surgical AG

Sold / distributed

International distribution to the countries of India, Iran, Korea, Saudi Arabia.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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