Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1480-2026

January 21, 2026

Class II

Product summary

Firm
Staar Surgical AG
Event
Event 98397
Status
Ongoing
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-1480-2026

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.