BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7813791 · Received August 24, 2018

    Report

    Report Number
    3006695864-2018-01732
    Event Type
    Injury
    Date Received
    August 24, 2018
    Date of Event
    July 25, 2018
    Report Date
    November 2, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE REPORTED ADVERSE EVENT IS KNOWN AND DOCUMENTED IN THE LABELING. ''POSSIBLE COMPLICATIONS RESULTING FROM LASIK FLAP CREATION INCLUDE... INCOMPLETE FLAP CREATION 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

    DATE OF EVENT: UNKNOWN/NOT PROVIDED. APPLICATIONS SUPPORT MANAGER GELLED LASER AND DID Z DEPTH AS WELL AS DOUBLE CHECKED CONES TO BE SURE ALL WERE ETCHED. FOUND EVERYTHING TO BE WITHIN SPECS, DISCUSSED TECHNIQUE AGAIN WITH THE ACCOUNT. NO CHANGES WERE MADE. FIELD SERVICE SPECIALIST PERFORMED OVERLAP CHECK AND SYSTEM MET SPECIFICATIONS. FSS REPLACED ARTICULATING ARM, ANALOG PRINTED CIRCUIT BOARD, DELIVERY SYSTEM GROMMETS AND BUSHINGS. FSS ALSO INSTALLED A GALVO INTERFACE PRINTED CIRCUIT BOARD ANALOG. HE COMPLETED TECHNICAL SERVICE BULLETINS, STANDARD SERVICE CALL TASK LIST AND PREVENTIVE MAINTENANCE. 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 A SURGEON HAD A PATIENT WITH AN INCOMPLETE FLAP IN THE RIGHT EYE. SURGEON SAID THE PROCEDURE LOOKED COMPLETELY NORMAL AND NO ISSUE WAS NOTED DURING RASTER. SURGEON WAS NOT ABLE TO ENTER THE SIDE CUT OR LOCATE IT. PROCEDURE WAS ABORTED. SURGEON INSISTED HE APPLANATED BEYOND THE YELLOW ZONE AND ALL WAS AS SHOULD BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654166 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC R20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other