BEUDAMED
    FDA Enforcement Class II Ongoing

    EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

    Recall: Z-1480-2026 · Reported March 11, 2026

    Enforcement

    Recall Number
    Z-1480-2026
    Event ID
    98397
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Staar Surgical AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    March 11, 2026
    Initiation Date
    January 21, 2026
    Classification Date
    March 2, 2026
    Address
    Haupt Strasse 104, N/A, Nidau, N/A, N/A, Switzerland

    Description

    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.

    Code Info

    UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988

    Distribution

    International distribution to the countries of India, Iran, Korea, Saudi Arabia.

    Quantity

    7