BEUDAMED
    FDA Enforcement Class II Ongoing

    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

    Recall: Z-0474-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0474-2024
    Event ID
    93312
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Staar Surgical Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    December 13, 2023
    Initiation Date
    September 29, 2023
    Classification Date
    December 1, 2023
    Address
    1911 Walker Ave, Monrovia, CA, 91016-4846, United States

    Description

    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

    Reason

    Their is a potential that intraocular implant devices may not meet specifications.

    Code Info

    Serial/UDI: S1746728/ (01)00841542122023(11)221120(17)241031(21)S1746728; S1713542/ (01)00841542122030(11)221026(17)240930(21)S1713542; S1746725/ (01)00841542122016(11)221120(17)241031(21)S1746725; S1707067/ (01)00841542122016(11)221022(17)240930(21)S1707067; S1734035/ (01)00841542122047(11)221111(17)241031(21)S1734035; S1713494/ (01)00841542122030(11)221026(17)240930(21)S1713494; S1713551/ (01)00841542122030(11)221026(17)240930(21)S1713551; S1740887/ (01)00841542122047(11)221115(17)241031(21)S1740887; S1713505/ (01)00841542122030(11)221026(17)240930(21)S1713505

    Distribution

    US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None

    Quantity

    9 units