Evo+ Visian Toric Implantable Collamer Lens (ticl), Model: Vticm5

Recall Summary EVO+ Visian Toric Implantable Collamer Lenses (Model VTICM5) are being recalled because some lenses labeled as 12.1 mm are actually 12.6 mm in length. The incorrect size can cause excessive vaulting inside the eye, potentially leading to reduced eye angles, shallow anterior chambers, eye discomfort, increased eye pressure, and in some cases requiring lens removal or replacement. This recall affects patients who received these lenses for vision correction and astigmatism.

Recalling firm

Staar Surgical AG Haupt Strasse 104 Nidau Switzerland

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.

Classification

Class III

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-21

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/d06764fe-9b4c-4ae8-b8f8-0d70f15ef993