BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2083716 · Received May 10, 2011

    Report

    Report Number
    9614546-2011-00031
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LENS WAS MEASURED FOR DIOPTER AND VERIFIED TO BE CORRECT AS LABELED, 20.0 DIOPTER. VISUAL INSPECTION OF THE OPTIC TOOK PLACE AND NO OPTICAL DEVIATIONS COULD BE FOUND. A REVIEW OF THE HISTORICAL COMPLAINT DATA BASE REVEALED THAT NO ADDITIONAL COMPLAINTS FROM THIS LOT NUMBER WERE RECEIVED. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED FOR ANALYSIS AND IS CURRENTLY UNDER EVALUATION AT THE MANUFACTURING SITE. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE INITIAL MULTIFOCAL IMPLANT WAS EXCHANGED FOR A MONOFOCAL LENS SUGGESTING THE PATIENT WAS NOT ABLE TO ADAPT TO THE HALOS AND GLARE, A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. ALL INFORMATION AVAILABLE IS CONTAINED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A SURGEON REPORTED THE MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED 1 YEAR AFTER INITIAL IMPLANT. REASON STATED WAS THE PATIENT'S DISSATISFACTION WITH THEIR VISION AND THE HALOS AND GLARE. THE MULTIFOCAL LENS WAS EXCHANGED FOR A MONOFOCAL WITHOUT COMPLICATION.

    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 75 YR Required Intervention