FDA recall, , Moderate risk
Staar Surgical EVO+ Visian Toric Implantable Collamer Lens (TICL)
The lens is labeled as 12.1 mm but is 12.6 mm, which may cause excessive vault.
Summary by Recall Canary from the FDA notice
What happened
Staar Surgical AG of Nidau, Switzerland, recalled the EVO+ Visian Toric Implantable Collamer Lens (TICL), Model VTICM5, on January 21, 2026, because the lenses were labeled as 12.1 mm length but are 12.6 mm length, which may cause excessive vault.
The potential for excessive vault may cause significant reduction of irido-corneal angles, significant shallowing of anterior chamber, patient discomfort, elevated IOP/angle closure, unreactive pupil, and lens exchange/removal. The FDA added the recall to its Enforcement Report and classified it on March 2, 2026. The lenses were distributed internationally to India, Iran, Korea, and Saudi Arabia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
EVO+ Visian Toric Implantable Collamer Lens (TICL)
- Model
- VTICM5
- UDI-DI
- 00840311304363
Recall details
- Company began the recall
- Sold in
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
- Company
- Staar Surgical AGNidau, Switzerland
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98397
- Recall number
- Z-1480-2026
All recalls from Staar Surgical AG
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated