BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT MEDICAL OPTICS

    MDR report key: 1445409 · Received August 19, 2009

    Report

    Report Number
    MW5012495
    Event Type
    Injury
    Date Received
    August 19, 2009
    Date of Event
    August 1, 2008
    Report Date
    August 19, 2009
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I WOULD LIKE TO REPORT A DEFECT IN THE MANUFACTURE OF ABBOTT MEDICAL OPTICS -AMO- PREVIOUSLY KNOWN AS ADVANCED MEDICAL OPTICS, INTRAOCULAR LENS -IOL- MODEL ZMAOO ACRYLIC MULTIFOCAL IOL. I HAVE IMPLANTED IN EXCESS OF 25 OF THESE LENSES DURING AND AFTER AUGUST 2008. THEY PRODUCED POOR OUTCOMES WITH REDUCED VISION AND EXCESSIVE OPTIC ABERRATIONS. EXHAUSTIVE INVESTIGATION POST OPERATIVELY, FOUND THAT THE PRODUCTION OF THE IOL WAS DEFECTIVE DUE TO THE DIAMOND LATHE CUTTING OF THE IOL. THEY CAUSED A GROUND GLASS HAZE ON THE POSTERIOR SURFACE OF THE IOL. I AM A MEDICAL DOCTOR FROM A FOREIGN COUNTRY. I HAVE MORE THAN 25 IOLS THAT I HAVE IMPLANTED THAT WERE DEFECTIVE. THE COMPANY REMOVED THE CONSIGNMENT BEFORE I WAS ABLE TO OPEN THE REST OF THEM TO LOOK FOR DEFECTS, BUT I HAVE CLINICAL PHOTOGRAPH OF MANY OF THE DEFECTIVE IOLS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT MEDICAL OPTICS TECNIS MULTIFOCAL INTRAOCULAR LENS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention