BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 2043506 · Received February 25, 2011

    Report

    Report Number
    3006723646-2011-00063
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 25, 2011
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LENS WAS EXPLANTED BECAUSE IT WAS ADVANCED TOO QUICKLY INTO THE EYE DURING LENS INSERTION. NO ALLEGED LENS DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISERT ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. PC-60AD

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention