BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 1587180 · Received January 15, 2010

    Report

    Report Number
    3006723646-2010-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 16, 2009
    Report Date
    January 15, 2010
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA SURGICAL OPTICS, INC. HAS REQUESTED MORE INFO FROM THE USER FACILITY.

    Description of Event or Problem · 1

    THE IOL WAS EXPLANTED WHEN THE HAPTIC TORE OFF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention