BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 1791689 · Received August 4, 2010

    Report

    Report Number
    3006723646-2010-00072
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 6, 2010
    Report Date
    August 4, 2010
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA SURGICAL OPTICS IS TRYING TO GET PT INFO FROM THE SURGICAL FACILITY.

    Description of Event or Problem · 1

    LENS WAS EXPLANTED AFTER THE OPTIC BROKE DURING INSERTION INTO THE EYE. PT WAS NOT INJURED. ANOTHER HOYA LENS WAS INSERTED WITH NO PROBLEM.

    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