BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICL IMPLANTABLE COLLAMER LENS

    MDR report key: 1002833 · Received February 26, 2008

    Report

    Report Number
    2023826-2008-00236
    Event Type
    Other
    Date Received
    February 26, 2008
    Report Date
    January 30, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS AND THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT TO DATE NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL IMPLANTABLE COLLAMER LENS INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY ICM125V4 NA

    Patients

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