BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL IOL

    MDR report key: 2021721 · Received March 9, 2011

    Report

    Report Number
    MW5019800
    Event Type
    Injury
    Date Received
    March 9, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS,
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2009, I TOOK THE OPTION OF HAVING THE TECNIS MULTIFOCAL IOL (LENSE) FROM (B)(6), FOR CATARACT SURGERY, (BOTH EYES) AT AN ADDITIONAL COST OF (B)(6) NOT COVERED BY (B)(6). THE IMPLANTS RESULTED IN EXTREME SENSITIVITY TO LIGHT. NIGHT LIGHTS CAUSED STARBURST GLARE SO EXTREME AS TO CAUSE BLINDNESS WHEN DRIVING. SUNGLASSES WERE NEEDED DURING DAYLIGHT AND GHOST IMAGES WERE SEEN WITH INDOOR LIGHTED OBJECTS. IN ADDITION, READING GLASSES WERE PRESCRIBED. PRIOR TO SURGERY, I RECEIVED A COMPANY BROCHURE WHICH STATED THE IMPLANTS WOULD RESTORE "YOUTHFUL VISION" WITH NO MORE NEED OF GLASSES. NO MENTION WAS MADE OF THE SIDE EFFECTS I WAS EXPERIENCING. WHEN I CONTACTED THE COMPANY, THEY REPLIED THAT "MY BRAIN" WAS THE PROBLEM AND OFFERED NO RECOURSE, STATING MY DOCTOR SHOULD HAVE ADVISED ME OF SUCH POSSIBLE OUTCOMES. I WAS ALSO ADVISED TO WAIT ABOUT 6-9 MONTHS FOR GRADUAL IMPROVEMENT. ON (B)(6) 2010, UPON ADVISEMENT OF MY DOCTOR, I DECIDED TO HAVE ONE LENSE REPLACED BY A MONOFOCAL LENSE. THIS HAS RESULTED IN IMPROVEMENT. I AM NOW DECIDING WHETHER TO REMOVE THE REMAINING LENSE. IN SUMMATION, THE SURGERY RESULTED IN EYESIGHT CONSIDERABLY WORSE THAN WHEN I HAD CATARACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL IOL MULTIFOCAL LENSE HQL ABBOTT MEDICAL OPTICS, ZMA00
    2 TECNIS MULTIFOCAL IOL MULTIFOCAL LENSE HQL ABBOTT MEDICAL OPTICS, ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention