BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7478729 · Received May 2, 2018

    Report

    Report Number
    3006695864-2018-00987
    Event Type
    Injury
    Date Received
    May 2, 2018
    Report Date
    May 1, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE COULD NOT DUPLICATE THE SIDE CUT NOT PRESENT. DUE TO REPEATED OCCURRENCE, THE GALVO BLOCK WAS REPLACED. THE SYSTEM WAS CLEANED AND ALIGNED. DURING EVALUATION OF THE DELIVERY SYSTEM, THE ENGINEER FOUND THE TRACKBALL WAS STUCK AND ENERGY WAS LOW, THEREFORE THE TRACKBALL WAS REPAIRED AND AMPLIFIER GLASS WAS REPLACED. ALL MODES OF OPERATION AND CALIBRATIONS WERE VERIFIED THE UNIT COMPLIED WITH ALL FACTORY SETTINGS. 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

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT EXPERIENCED AN INCOMPLETE SIDE CUT ON THE RIGHT EYE (OD) RESULTING IN THE ABORTING THE PROCEDURE. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE SURGEON ATTEMPTED TO LIFT THE OD FLAP BUT WAS UNABLE TO SEE THE SIDE CUT. THE PROCEDURE WAS ABORTED AND A BANDAGE CONTACT LENS WAS PLACED. THE LEFT EYE (OS) WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON STATED IT APPEARED THAT BOTH EYE (OU) TREATMENTS WERE NORMAL AND DID NOT SEE ANYTHING UNUSUAL DURING THE RASTER PATTERN OR SIDE CUT. THE SURGEON COULD SEE A FAINT TRACE OF THE SIDE CUT BUT WAS UNABLE TO LIFT. THE PATIENT PROCEDURE WAS POSTPONED AND THE PROCEDURE WILL BE CONVERTED TO A PHOTOREFRACTIVE KERATECTOMY (PRK) ONCE THE VISION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323655 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC R20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention