BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2223567 · Received August 25, 2011

    Report

    Report Number
    9614546-2011-00075
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    June 8, 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 Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IN FOLLOW-UP WITH THE SURGEON HE STATED THE MULTIFOCAL INTRAOCULAR LENS WAS NOT DEFECTIVE. PATIENT WAS NOT ABLE TO ADJUST TO THE MULTIFOCALITY OF THE LENS. LENS WAS DISCARDED AT THE SURGERY CENTER AND NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORD WAS PERFORMED AND MET ALL SPECIFICATIONS. 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 INTRAOCULAR LENS WAS NOT RECEIVED FOR ANALYSIS FOLLOWING EXPLANT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON HAVE TO DATE BEEN UNSUCCESSFUL. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL INTRAOCULAR LENSES. OUR INVESTIGATION IS INCONCLUSIVE AT THIS TIME. 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. LENS NOT RECEIVED.

    Description of Event or Problem · 1

    A PATIENT REPORTED THE EXCHANGE OF HER MULTIFOCAL INTRAOCULAR LENS FOR A MONOFOCAL INTRAOCULAR APPROXIMATELY 1 YEAR AFTER INITIAL IMPLANT. THE PATIENT REPORTED SHE EXPERIENCED SEVERE HALOS, STREET LIGHTS FORMING A CONTINUOUS LINE. IN CERTAIN LIGHT SHE SAW ZIG-ZAGS OF LIGHT FLASHING IN HER VISION. SHE REPORTED SHE COULD NOT DRIVE AT NIGHT AT ALL, AND HAD SUCH IMPAIRED VISION, THAT SHE DROVE VERY LITTLE EVEN DURING THE DAY AND NOT AT ALL ON BRIGHT DAYS. SHE REPORTED EYESTRAIN AND CLOUDY VISION.

    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 66 YR Required Intervention