BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7539681 · Received May 24, 2018

    Report

    Report Number
    3006695864-2018-01174
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    April 19, 2018
    Report Date
    May 23, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    UDI-DI
    05050474573451
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING 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 AND 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 AND PRESENTED ON (B)(6) 2018 WITH MILD RECURRENT EROSION IN RIGHT EYE (OD) POST TREATMENT. TOPICAL STEROID DOSAGE WAS INCREASED. THE PATIENT WAS TREATED WITH MURO OINTMENT TO BE TAPERED OFF. IT WAS STATED THAT THE PATIENT DID NOT EXPERIENCE LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT¿S CHIEF COMPLAINTS WERE OF BLURRED VISION, HALOS, GLARES, AND SHADOWS. THE PATIENT COMMENTED BEING HAPPY. THE PATIENT REPORTED THE SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. AT THIS TIME, THE PATIENT IS BEING MANAGED. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -5.75 X -1.25 X 95, LEFT EYE PRE-OP 20/20 -5.75 X -1.50 X 100. BCVA FROM (B)(6) 2018: RIGHT EYE POST-OP 20/20 .00 X .00 X 90, LEFT EYE POST-OP 20/20 .00 X .00 X 90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382211 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention WAVELIGHT SERIAL (B)(4)