BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7725467 · Received July 27, 2018

    Report

    Report Number
    9614546-2018-00727
    Event Type
    Injury
    Date Received
    July 27, 2018
    Report Date
    November 2, 2020
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 · 0

    DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION ; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UPCOMING SYMFONY INTRAOCULAR LENS (IOL) EXPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568636 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON AND JOHNSON SURGICAL VISION, INC. ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention