BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7844717 · Received September 4, 2018

    Report

    Report Number
    3006695864-2018-01792
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    August 11, 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
    CA, 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). AN APPLICATIONS SUPPORT MANAGER WAS ON SITE AT THE TIME OF THE EVENT. SHE GELLED THE SYSTEM AND HAD TO INCREASE THE BED ENERGY. SHE OPTIMIZED THE SURGICAL SETTINGS AND REMAINING FLAPS WERE EASILY LIFTED FOR THE REMAINDER OF THAT DAY. FIELD SERVICE SPECIALIST (FSS) VISITED THE ACCOUNT AFTER THE EVENT. PREVENTIVE MAINTENANCE WAS COMPLETED. LASER MEETS MANUFACTURER'S SPECIFICATION. STICKY FLAPS WERE DUE TO AMPLIFIER GLASS LOW POWER OUTPUT. AMPLIFIER GLASS WAS REPLACED. EQUIPMENT LABELING CONTAINS ADEQUATE WARNINGS RELATED TO POSSIBLE COMPLICATIONS AND FLAP TEARING IS ONE OF THEM. 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 PATIENT HAD A DIFFICULT LIFT WHICH RESULTED WITH A TORN FLAP NEAR THE HINGE ON THE RIGHT EYE. SURGEON ABORTED THE CASE FOR THE RIGHT EYE, INSERTED A BANDAGE CONTACT LENS (BCL). SURGEON SUCCESSFULLY LIFTED AND COMPLETED THE EXCIMER PROCEDURE ON THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684603 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention