BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 15349522 · Received September 2, 2022

    Report

    Report Number
    3012236936-2022-02319
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 8, 2022
    Report Date
    September 2, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K063682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GENDER: UNKNOWN; PATIENT WEIGHT: UNKNOWN; ETHNICITY AND RACE: UNKNOWN. (B)(4). DEVICE EVALUATION: FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND FOUND THAT LASER WAS CUTTING ON THE THIN SIDE, CONE THAT WAS USED WAS CREATING FLAPS ABOUT 8UM THINNER THAN TARGETS, AND DOCTOR SETTINGS FOR A 100UM FLAP THICKNESS, ALL THESE FACTORS CONTRIBUTED TO THE VERTICAL GAS BREAKTHROUGH (VGB). FSE CALIBRATED Z DEPTH ABOUT 10UM THICKER, THIS WILL MITIGATE ANY FUTURE CONES VARIATION. THE SYSTEM MEETS SPECIFICATION. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS VERTICAL GAS BREAKTHROUGH (VGB) ON ONE OF THE PATIENT¿S LEFT EYES. SURGEON SWITCHED TO PRK (PHOTOREFRACTIVE KERATECTOMY) TO COMPLETE CASE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314871 INTRALASE FS2 POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown Required Intervention