BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 8167027 · Received December 14, 2018

    Report

    Report Number
    3006695864-2018-02226
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    November 20, 2018
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION
    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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2018. IT WAS NOTED THAT PATIENT HAD INFECTION WITH SUBOPTIMAL RESULTS. ON (B)(6) 2018, PATIENT FELT A FOREIGN BODY SENSATION IN THE LEFT EYE (OS (OCULAR SINISTER)), THINKS IT¿S AN EYELASH, TRIES TO REMOVE IT, PURCHASE OVER THE COUNTER EYE DROPS, THINKS HE¿S ALLERGIC TO AN INGREDIENT IN IT. EVEN EXPLAINS THIS TO THE SURGEON DURING THE POST OP COMPLAINT. SURGEON NOTES AN INFECTION AND STEROIDS WERE INCREASED. PATIENT IS FINE, HAS HEALED AND VISUAL ACUITY (VA) IS FINE. POST-OP DAY 1: (B)(6) 2018 ¿ UNCORRECTED VISUAL ACUITY (UCVA) 20/20; POST-OP 1 MONTH: (B)(6) 2018 ¿ UCVA 20/20. THIS REPORT IS FOR THE FEMTO LASER EQUIPMENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE VISX LASER EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006302 INTRALASE FS3 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VISX SERIAL NO. (B)(6)