Recall
FDAHealthJanuary 21, 2026

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

⚠️ 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.

Is this relevant to me?

Geography
Unknown
Source agency
FDA
Category
Health
Published
January 21, 2026

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

What's affected?

Product
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Lot code
UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988

Additional details

UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 7.

View original FDA notice →

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