BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 7471160 · Received April 28, 2018

    Report

    Report Number
    3006695864-2018-00957
    Event Type
    Injury
    Date Received
    April 28, 2018
    Date of Event
    March 31, 2018
    Report Date
    April 27, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    UDI-DI
    05050474573468
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 & 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 TRACE OF DIFFUSE LAMELLAR KERATITIS (DLK) IN BOTH EYES(OU)POST TREATMENT. THE SURGERY CENTER NOTED THERE WAS MORE DLK IN THE LEFT EYE THAN THE RIGHT EYE. TOPICAL STEROID DOSAGE WAS INCREASED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT¿S COMMENTS WERE OF SATISFACTION WITH VISION BUT EYES FELT SCRATCHY; MORE ON THE LEFT EYE THAN THE RIGHT EYE. THE PATIENT REPORTED THE SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -4.50 X -.50 X 9, LEFT EYE PRE-OP 20/20 -4.25 X -1.25 X 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313754 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention