EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
FDA Recall #Z-1480-2026 — Class II — January 21, 2026
Product Description
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
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.
Recalling Firm
Staar Surgical AG — Nidau, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7
Distribution
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
Code Information
UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated