BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 2852278 · Received November 12, 2012

    Report

    Report Number
    3006723646-2012-00259
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 12, 2012
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE DOCTOR WAS BEGINNING TO INSERT THE LENS THEY NOTICED THAT THE TRAILING HAPTIC WAS BROKEN. LENS WAS NOT FULLY INSERTED. LENS HAD TO BE EXPLANTED.

    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 Required Intervention