BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 8824800 · Received July 24, 2019

    Report

    Report Number
    3006695864-2019-00607
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    June 29, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    UDI-DI
    05050474573468
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 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) 2019 AND PRESENTED WITH AN INCOMPLETE FLAP IN THE LEFT OPERATIVE EYE (OS). PATIENT HAD A LOSS OF EPITHELIUM WHICH APPEARED TO HAVE SUBCLINICAL ABMD (ANTERIOR BASEMENT MEMBRANE DYSTROPHY). TREATMENT WAS ABORTED. A BANDAGE CONTACT LENS (BCL) WAS APPLIED. NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) WAS REPORTED. THE PATIENT REPORTED THE SYMPTOMS WERE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2019: RIGHT EYE PRE-OP 20/20 4.50 X -.75 X 27. LEFT EYE PRE-OP 20/20 4.00 X -.25 X 112.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617220 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention