Z-1480-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2026
- Initiation Date
- January 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Reason for Recall
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.
Distribution Pattern
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
Code Information
UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988