Recall Z-1480-2026— Staar Surgical AG
Class II · Ongoing
Class II FDA medical device recall by Staar Surgical AG, initiated 2026-01-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Staar Surgical AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-01-21
- Firm location
- Nidau, N/A, Switzerland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.