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

Medical DevicesSource: FDA (device) · Date: 2026-03-11

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Staar Surgical AG
Product
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
Recall initiated
2026-01-21
Code info
UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
Product quantity
7
Voluntary mandated
Voluntary: Firm initiated
City
Nidau
State
N/A
Country
Switzerland
Event id
98397
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