BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 2081871 · Received April 5, 2011

    Report

    Report Number
    3006723646-2011-00109
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LENS WAS EXPLANTED BECAUSE A HAPTIC BROKE DURING LENS INSERTION. PATIENT PROGNOSIS IS GOOD.

    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 67 YR Required Intervention