FDA Medical devices recall ·
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 recall
- Recall number
- Z-1480-2026
- Date
- (initiated January 21, 2026)
- Company / brand
- Staar Surgical AG
Haupt Strasse 104, Nidau, N/A, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
Distribution
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1480-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.