BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IFS

    MDR report key: 9447792 · Received December 10, 2019

    Report

    Report Number
    3006695864-2019-00965
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 9, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    UDI-DI
    05050474547698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H4: ADDITIONAL: THE DEVICE MANUFACTURER DATE WAS PROVIDED AS 06/03/2008. H4 OF THIS FOLLOW UP HAS BEEN UPDATED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED. H3 OTHER TEXT : PLACEHOLDER.

    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

    PHONE NUMBER: (B)(6). MANUFACTURING DATE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REQUEST. FIELD SERVICE SPECIALIST (FSS) VISITED THE ACCOUNT AND WAS NOT ABLE TO CONFIRM THE REPORTED ISSUE. HE PREVENTIVELY REPLACED POWER SUPPLY AC/DC (ALTERNATE/DIRECT CURRENT) SWITCHER AND ASSEMBLY POWER SUPPLY. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, 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

    ACCOUNT REPORTED ERROR MESSAGE OCCURRED WHEN CREATING THE POCKET AREA OF THE INTRALASE FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238627 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. J20007J 05050474547698

    Patients

    Seq Age Sex Outcome Treatment
    1