BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7838480 · Received August 31, 2018

    Report

    Report Number
    3006695864-2018-01788
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    August 9, 2018
    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
    UT, 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

    (B)(4). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER AND CLINICAL SUPPORT. THE FIELD SERVICE FOUND NO ISSUES WITH THE UNIT. A FIELD SERVICE CHECKLIST WAS PERFORMED. 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

    DR. (B)(6) HAD A VERTICAL GAS BREAKTHROUGH/INCOMPLETE FLAP CONCERNS ON PATIENT'S RIGHT EYE (OD). PATIENT'S OD HAD VERTICAL GAS BREAKTHROUGH WITHOUT OPAQUE BUBBLE LAYER (OBL), 90UM FLAP WITH POCKET TURNED ON. UNABLE TO LIFT AND CONVERTED TO PHOTOREFRACTIVE KERATECTOMY (PRK) THAT MOMENT. FOR THE LEFT EYE (OS), DR. (B)(6) ELECTED TO CHANGE THE FLAP THICKNESS TO 100UM WITH NO PROBLEMS, FLAP CREATED, LIFTED AND EXCIMER COMPLETED. TECHNICAL SUPPORT DISCUSSED WITH DR. (B)(6) AGAIN THE INCREASED RISKS WIT 90UM FLAPS WITH HER RE-STATING THE DOCTOR HAS BEEN DOING THIS FOR 10 YEARS WITHOUT CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679857 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention