BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS MULTIFOCAL IOL

    MDR report key: 2109239 · Received May 26, 2011

    Report

    Report Number
    MW5020768
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 18, 2011
    Manufacturer
    AMO HEADQUARTERS
    Product Code
    MFK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I AM WRITING THIS LETTER TO REPORT THE RECENT EXPLANT I HAD TO PERFORM ON ONE OF MY PATIENTS. SHE HAD UNDERGONE UNEVENTFUL KPE WITH IMPLANTATION OF A TECNIS MFIOL. THIS LENS HAD BEEN IMPLANTED IN HER NON-DOMINANT EYE. ALTHOUGH SHE EXPERIENCED DIFFICULTY WITH LIGHTS AND GLARE RIGHT AFTER HER SURGERY, SHE WAITED FOR THREE MONTHS TO SEE IF THE DIFFICULTIES WOULD SUBSIDE. UNFORTUNATELY THEY DID NOT, AND THE TECNIS MFIOL WAS EXPLANTED AND REPLACED WITH A MONOFOCAL IOL. I AM ENCLOSING COPIES OF THE PT'S SKETCHES WHICH WERE BROUGHT IN TO HELP US UNDERSTAND HER DIFFICULTIES WITH THE TECNIS MULTIFOCAL IMPLANT. BECAUSE I AM SEEING MORE PATIENTS EXPERIENCING DIFFICULTY WITH MULTIFOCAL IMPLANTS, I PLAN TO SEND A SHORT REPORT TO THE FDA OPHTHALMIC PANEL REGARDING ANY EXPLANTS PERFORMED ON MULTIFOCALS OR ACCOMMODATING IOLS WHEN THESE ARE DONE FOR QUALITY OF VISION ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL IOL TECNIS MFK AMO HEADQUARTERS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR