EVO+ Visian Toric Implantable Collamer Lens recall
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Why was EVO+ Visian Toric Implantable Collamer Lens 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
- Product
- EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- Recalling firm
- Staar Surgical AG
- Quantity
- 7
- Distribution
- International distribution to the countries of India, Iran, Korea, Saudi Arabia.
- Recall date
- March 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)