BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 8158444 · Received December 12, 2018

    Report

    Report Number
    9614546-2018-01165
    Event Type
    Injury
    Date Received
    December 12, 2018
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474605817
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. (B)(4). IT WAS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD, LABELING, 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 · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) (NON-DOMINANT EYE) ON (B)(6) 2018. POST-OPERATIVELY, THE PATIENT COMPLAINED OF HAVING NO CLEAR VISION AT ANY DISTANCE, SEEING MULTIPLE IMAGES AT ALL DISTANCES, AND EXTREME HALOS AND STARBURSTS AT NIGHT. THE PATIENT ALSO COMPLAINED OF SEEING AT LEAST 3 IMAGES WHEN LOOKING AT A MAIN OBJECT (GHOST IMAGES) AT 7 AND 2 O'CLOCK AND AT DISTANCES AND THAT IT'S JUST A BLUR OVER 60 FEET. THE PATIENT ALSO SEES CONCENTRIC RINGS WHEN LOOKING AT LIGHTS AT NIGHT. THE PATIENT HAS TRIED COVERING HIS DOMINATE EYE WITH A PATCH TO SEE IF BRAIN WOULD ADAPT, BUT HAS NOT BEEN SUCCESSFUL. REPORTEDLY, IT'S BEEN 10 MONTHS POST-OPERATIVELY WITH NO IMPROVEMENT. ALSO, THE PATIENT HAS HAD A YTTRIUM-ALUMINUM GARNET (YAG) PERFORMED, BUT WITH NO IMPROVEMENT. THE PATIENT HAS ALSO STATED THAT THE ONE GOOD PART ABOUT THE LENS IMPLANTED IS THAT THE COLORS ARE NICE. THE PATIENT HAS TRIED A CONTACT LENS AND TAKING REFRESH OPTIVE ADVANCED EYE DROPS 3-4 TIMES PER DAY. ALSO, THE PATIENT SAW A SPECIALIST WHO STATED THE SURGERY LOOKED WELL AND THE LENS IS POSITIONED CAREFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994335 TECNIS SYMFONY TORIC MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT225 05050474605817

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other