BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 9275889 · Received November 4, 2019

    Report

    Report Number
    3006695864-2019-00872
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    October 15, 2019
    Report Date
    November 6, 2020
    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
    MN, 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 NR-0148919 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 ON (B)(6) 2019 WITH LOOSE EPITHELIUM OF BOTH EYES. THERE WAS IRREGULAR EPITHELIUM AND HAZE OF THE RIGHT EYE AND EPITHELIAL BASEMENT MEMBRANE DYSTROPHY (EBMD) OF BOTH EYES. BANDAGE CONTACT LENSES WERE PLACE IN BOTH EYES. THE PATIENT REPORTED BLURRY VISION WITH THE RIGHT EYE GREATER THAN THE LEFT AND HAD CONCERNS WITH OUTCOMES. IT WAS STATED THAT THE PATIENT DID NOT EXPERIENCE LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). PATIENT SYMPTOMS WERE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2019: RIGHT EYE PRE-OP 20/20 -6.75 X -1.75 X 7, LEFT EYE PRE-OP 20/20 -7.50 X -.50 X 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065881 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention WAVELIGHT 1010-3-259