BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1081264 · Received July 24, 2008

    Report

    Report Number
    2023826-2008-01000
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    July 3, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS IN 2008. THE REPORTER STATED THE PT HAS DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME. ADD'L INFO HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK