BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 9653061 · Received January 31, 2020

    Report

    Report Number
    3006695864-2020-00072
    Event Type
    Injury
    Date Received
    January 31, 2020
    Date of Event
    January 3, 2020
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 · 0

    H4: ADDITIONAL: THE DEVICE MANUFACTURER DATE WAS PROVIDED AS 11/22/2006. 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 · 1

    DEVICE MANUFACTURE DATE NOT AVAILABLE AT THE TIME OF THIS REPORT. (B)(4). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE) AND COULD NOT DUPLICATE REPORTED ISSUE. THE FSE PERFORMED A Z CALIBRATION CHECK AND PERFORMED A BURN IN TEST FOR 30 PROCEDURES WITH NO ERRORS AND FOUND SYSTEM WAS WITHIN SPECIFICATIONS. THE FSE PERFORMED FULL SYSTEM VERIFICATIONS AND SYSTEM MET J&J VISION SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A LASER VISION CORRECTION TREATMENT, AT THE START OF THE SIDE CUT, THE LASER SYSTEM GAVE AN ERROR -209 Z-STEPPER POSITION CHECK MESSAGE. THE ERROR MESSAGE PREVENTED THE FLAP CREATION. THE PLANNED PROCEDURE WAS ABORTED AND WAS CONVERTED TO A (PRK)PHOTOREFRACTIVE KERATECTOMY (PRK) TREATMENT INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115909 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PI LOT #60176687