BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 8057602 · Received November 9, 2018

    Report

    Report Number
    9614546-2018-01066
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    September 6, 2018
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474605800
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS INSERTED AND REMOVED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS INSERTED AND REMOVED. 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. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZXT225 20.5 DIOPTER LENS WAS INSERTED AND THEN REMOVED FROM THE PATIENT'S LEFT EYE DURING THE SAME PROCEDURE BECAUSE A SCRATCH WAS NOTICED AFTER BEING IMPLANTED. AN INCISION ENLARGEMENT WAS PERFORMED AND THE LENS WAS REMOVED AND THEN REPLACED WITH THE SAME MODEL AND DIOPTER LENS. THERE WAS NO VITRECTOMY PERFORMED AND NO SUTURES USED. REPORTEDLY, THE SURGEON BELIEVES THE TECH LOADED THE LENS WRONG. THE LENS WAS DISCARDED BY THE SURGERY CENTER AND THEREFORE NOT AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896647 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT225 05050474605800

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention