BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 1993637 · Received January 6, 2011

    Report

    Report Number
    3006723646-2011-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 6, 2011
    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 BELIEVES THERE IS NO PRODUCT DEFECT.

    Description of Event or Problem · 1

    LENS WAS EXPLANTED AFTER DOCTOR REALIZED THE WRONG DIOPTER WAS USED.

    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 87 YR Required Intervention