BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 8198152 · Received December 26, 2018

    Report

    Report Number
    3006695864-2018-02244
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    November 16, 2018
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE SURGERY CENTER HAS MADE THE FOLLOWING CHANGES: CHANGED FROM REUSABLE TO DISPOSABLE CANNULAS; STARTING A NEW LASIK SUITE LOGGING SYSTEM ( STERILITY ); EVERYONE TO WEAR MASKS AND BOOTIES IN SURGERY SUITE; SWITCH TO DISPOSABLE MARKERS; WILL NOT USE STERILE GLOVES, STERILE DRAPES; USES BETADINE - POST LASIK GET VIGAMOX / PF AND AT HOME WITH BLINK TEARS. ALTERNATE QHR , 2ND DAY TAPER THEN 1W FROM QID. PRK PATIENTS GET LONGER WITH DROPS AND BCL. A FIELD SERVICE SPECIALIST VISITED SITE AND PERFORMED LASER CHECK, PERFORMED PREVENTATIVE MAINTENANCE (PM), TESTED THE LASER. NO PROBLEMS FOUND. SYSTEM MEETS JOHNSON & JOHNSON SURGICAL VISION SPECIFICATIONS. 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 INTACTS PROCEDURE IN RIGHT EYE ON (B)(6) 2018 TO TREAT KERATOCONUS BEFORE HAVING CROSS LINKING. DISSOLVABLE SUTURES WERE USED AT EVERY CROSS. POST TREATMENT PATIENT PRESENTED WITH A SMALL DOT BEHIND A SUTURE THAT COULD HAVE BEEN IRRITATION BUT DOCTOR BELIEVES IS INFECTION. UNCORRECTED VISUAL ACUITY IS 20/40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035531 INTRALASE FS3 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other