BEUDAMED
    FDA Enforcement Class II Ongoing

    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.

    Recall: Z-0472-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0472-2024
    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: VTICM5_13.2. Phakic Toric Intraocular lens.

    Reason

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

    Code Info

    T1307122/ (01)00841542116152(11)230109(17)241231(21)T1307122; T1485436/ (01)00841542115735(11)230503(17)250430(21)T1485436; T1257531/ (01)00841542116169(11)221122(17)241031(21)T1257531; T1365550/ (01)00841542115933(11)230214(17)250131(21)T1365550; T1511722/ (01)00841542116053(11)230522(17)250430(21)T1511722; T1187957/ (01)00841542116299(11)220926(17)240831(21)T1187957; T1342243/ (01)00841542116992(11)230131(17)241231(21)T1342243; T1367644/ (01)00841542116305(11)230216(17)250131(21)T1367644; T1205475/ (01)00841542116763(11)221010(17)240930(21)T1205475; T1387400/ (01)00841542116411(11)230301(17)250131(21)T1387400; T1228382/ (01)00841542116534(11)221030(17)240930(21)T1228382

    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

    11 UNITS