BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2030037 · Received March 25, 2011

    Report

    Report Number
    9614546-2011-00018
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040/S029
    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, 21.0 DIOPTER. VISUAL INSPECTION OF THE OPTIC PARTS 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 NOT RECEIVED FOR ANALYSIS. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL BUT INSTEAD BY THE PATIENT'S INABILITY TO ADAPT TO THE MULTIFOCALITY OF THE LENS. 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 WITHOUT COMPLICATION 5 WEEKS AFTER INITIAL IMPLANT. REASON STATED WAS THE PATIENT'S HALOS AND GLARE, A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1