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
- Brand
- Staar Surgical AG
- 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.
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