BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2221104 · Received August 23, 2011

    Report

    Report Number
    2648035-2011-00184
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORD WAS PERFORMED AND MET SPECIFICATIONS. OUR INVESTIGATION SUGGESTS THIS EVENT WAS NOT CAUSED BY A DEFICIENT INTRAOCULAR LENS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE MULTIFOCAL INTRAOCULAR LENS HAS NOT YET BEEN RECEIVED FOR ANALYSIS. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE TO MARKET. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FOLLOWING IMPLANT WITH A MULTIFOCAL INTRAOCULAR LENS THE PATIENT REPORTED HE WAS NOT COMFORTABLE DRIVING AT NIGHT.. VISUAL ACUITY RESULTS WERE 20/20. SURGEON FELT HE HAD A BAD PATIENT SELECTION. THE LENS WAS EXCHANGED FOR A MONOFOCAL LENS 4 MONTHS AFTER INITIAL SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention