BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 9693762 · Received February 11, 2020

    Report

    Report Number
    3006695864-2020-00100
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    January 11, 2020
    Report Date
    November 2, 2020
    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
    IL, 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) 2020 AND PRESENTED ON (B)(6) 2020 WITH MICROSTRIAE OVER THE VISUAL AXIS IN THE LEFT EYE (OS), POST TREATMENT. A FLAP LIFT AND STRETCH WAS PERFORMED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF HOURGLASS GLARE IN OS, CLEAR VISION. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. THE PATIENT'S SYMPTOMS RESOLVED ON (B)(6) 2020. BCVA FROM (B)(6) 2019. RIGHT EYE PRE-OP 20/20 -3.00 X .00 X 90, LEFT EYE PRE-OP 20/20 -3.00 X .00 X 90. BCVA FROM (B)(6) 2020. RIGHT EYE POST-OP 20/15 .00 X .00 X 90, LEFT EYE POST-OP 20/15 .00 X .00 X 90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159727 IFS FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention WAVELIGHT SERIAL NUMBER (B)(6)