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Staar Surgical AG recalls EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Recalled March 11, 2026 · FDA recall Z-1480-2026 · Staar Surgical AG
Hazard
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. · FDA Class II
Units
7
Sold at
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
Description
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.
Product
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Manufacturer(s)
Staar Surgical AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →