BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 8495292 · Received April 9, 2019

    Report

    Report Number
    3006695864-2019-00296
    Event Type
    Injury
    Date Received
    April 9, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    UDI-DI
    05050474573468
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    DATE OF EVENT: UNKNOWN/NOT PROVIDED. FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AFTER THE EVENT AND FOUND AN ORANGEPEEL OR SHUTTER EFFECT IN THE GEL. REMOVED AND REPLACED GALVO BLOCK. GEL MELT WAS MUCH CLEANER. PERFORMED CENTRATION SIDE CUT RETRACE SPATIAL ALIGNMENT AND VERIFIED Z-BASELINE. NO FURTHER PROBLEMS VISIBLE AT THIS TIME. LASER SETTINGS WERE ALSO OPTIMIZED. 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

    IT WAS REPORTED THAT ABOUT 6 WEEKS AGO FROM (B)(6) 2019 SURGEON HAD A PATIENT WITH AN INCOMPLETE AREA DURING THE RASTER PATTERN - LIKE A BLACK AREA. THE FLAP THICKNESS WAS PROGRAMMED AT 120UM HOWEVER THERE WERE NO CORNEAL CONCERNS. SITE ROUTINELY USES TETRACAINE SEVERAL TIMES PRIOR TO INTRALASE FLAP CREATION. SURGEON ABORTED THE FLAP LIFT AND HAS CHOSE TO COMPLETE PHOTOREFRACTIVE KERATECTOMY AT A LATER DATE STILL TO BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290979 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention