BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16196818 · Received January 18, 2023

    Report

    Report Number
    3012236936-2023-00084
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 18, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474751293
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    RECEIVED REPORT INDICATING THE JNJ IOL WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE IOL WAS EXPLANTED BECAUSE THEY COULD NOT SEE STREET SIGNS UNLESS THEY WERE UP CLOSE. REPORTEDLY, SHE STARTED LOSING DISTANCE VISION. SHE ALSO SAW SHADOWS AND LOST CONTRAST IN COLORS AS THOUGH SHE HAD LOST 10% OF BLACK IN HER VISION. SHE HAS DIFFICULTY READING HER COMPUTER AND WHEN SHE COVERS ONE EYE THE OTHER OBJECTS APPEAR TO BE IN DIFFERENT PLACES. CONSEQUENTLY THE PATIENT DID NOT FEEL COMFORTABLE WALKING AS SHE WAS AFRAID TO FALL. PATIENT WANTED TO COVER HER EYE WITH A PATCH BUT WAS CONCERNED IF IT WOULD STRAIN HER OTHER EYE. SHE ALSO INQUIRED ABOUT POSSIBLE ISSUE WITH HAVING THE IOL EXPLANTED. SHE WAS ADVISED TO FOLLOW-UP WITH HER DOCTOR. REPORTEDLY, THE DOCTOR INFORMED HER SHE HAS SMALL PUPILS. SHE HAS NO OTHER EYE HEALTH ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068750 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFW150 05050474751293

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention