EVO+ Visian Toric Implantable Collamer Lens recall (Staar Surgical AG)
Medical deviceClass IIOngoing
Summary: Staar Surgical AG is recalling EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5. Reason: 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 is being recalled
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
How to tell if yours is affected
UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1480-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 21, 2026 |
| Reported | March 11, 2026 |
| Company | Staar Surgical AG |
| Company location | Nidau, N/A, Switzerland |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7 |
More recalls from Staar Surgical AG · all medical device recalls · recalls from January 2026