BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1844526 · Received September 26, 2010

    Report

    Report Number
    2648035-2010-00184
    Event Type
    Injury
    Date Received
    September 26, 2010
    Date of Event
    July 6, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED FOR ANALYSIS AND THE OPTIC POWER MEASURED CORRECT AS LABELED, 17.5 DIOPTERS. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND ALL REPORTS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MULTIFOCAL INTRAOCULAR LENS WAS REMOVED AND REPLACED WITHOUT COMPLICATION 4 MONTHS AFTER THE INITIAL IMPLANT DUE TO A REFRACTIVE ERROR. THE INCORRECT DIOPTER WAS CHOSEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention