BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1480-2026 · Initiated January 21, 2026

    Recall

    Recall Number
    Z-1480-2026
    Event Number
    98397
    Firm
    Staar Surgical AG Haupt Strasse 104 Nidau Switzerland
    FEI Number
    3002808259
    Product Code
    QCB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 21, 2026
    Posted
    March 2, 2026

    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.

    Action

    On 1/21/2026, a Field Safety Notice was mailed to customers who were asked to do the following: 1. If any of the devices identified in the Field Safety Notice Return Response form have not already been implanted, remove them from your inventory and quarantine the product. 2. Complete the Field Safety Notice Return Response form indicating if each device has been implanted or is in your possession. 3. Complete and email the Field Safety Notice Return Response form to [email protected]. 5. Return affected devices to the firm. Should you have any questions, contact the firm's Representative or Customer Service at [email protected] or by phone at +41323328888 Monday through Friday, 8:00am to 5:00pm CET.

    Distribution

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

    Quantity

    7