BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7668380 · Received July 6, 2018

    Report

    Report Number
    9614546-2018-00643
    Event Type
    Injury
    Date Received
    July 6, 2018
    Date of Event
    June 7, 2018
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474575585
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE LENS WAS NOT IMPLANTED AND THEREFORE NOT EXPLANTED. (B)(6). 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 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE INTRAOCULAR LENS (MODEL ZXR00 +19.0 DIOPTER) WAS MISSING, WHEN THE LENS CASE WAS OPENED. REPORTEDLY, THE SURGERY HAD TO BE STOPPED MID-WAY FOR 1.5 HOURS UNTIL THE REPLACEMENT LENS WAS PROVIDED FOR THE SURGERY. THE SURGERY RESULTS WERE REPORTED AS SATISFACTORY. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PHACO EMULSIFICATION PROCEDURE HAD BEEN COMPLETED WHEN THEY FOUND THAT THERE WAS NO LENS IN THE LENS CASE. THE PATIENT WAS BROUGHT TO ANOTHER ROOM (COVERING THE OPERATED EYE WITH A BANDAGE). AFTER ONE AND HALF HOURS, THEY BROUGHT THE PATIENT BACK TO THE OPERATING THEATER, APPLIED AN ANESTHESIA, AND THEN IMPLANTED THE BACK-UP LENS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510189 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON AND JOHNSON SURGICAL VISION, INC. ZXR00 05050474575585

    Patients

    Seq Age Sex Outcome Treatment
    1 Other