BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 8670007 · Received June 5, 2019

    Report

    Report Number
    3006695864-2019-00454
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    May 7, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    UDI-DI
    05050474540231
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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). (B)(6). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER FOR THE REPORTED DECENTERED FLAP ISSUE. THE FLAPS ON GELS WERE CHECKED AND THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE FIELD SERVICE ENGINEER RESEATED ALL CONNECTIONS BETWEEN ANALOG I/O, GALVO INTERFACE AND GALVO DRIVES. COMPLETE VERIFICATION OF DELIVERY SYSTEM ALIGNMENT WAS PERFORMED AND THE SYSTEM WAS RELEASED FOR USE. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS 8/31/2009, HOWEVER THE CORRECT DATE IS 09/22/2009. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LASER CREATED A DECENTERED FLAP DURING OPERATION AND TREATMENT WAS ABORTED. THE PATIENT RETURNED THE FOLLOWING WEEK FOR COMPLETION OF LASER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463825 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20005K 05050474540231

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention