BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7573495 · Received June 6, 2018

    Report

    Report Number
    3006695864-2018-01306
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 12, 2018
    Report Date
    June 6, 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 & 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 TEMPORAL STRIAE IN BOTH EYES. A FLAP AND RINSE (FLAP STRETCHED) WAS PERFORMED. IT WAS STATED THAT THE PATIENT HAD NO A LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT¿S COMMENTS WERE OF BLURRED VISION AND DRY EYE. THE PATIENT REPORTED THE SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/25 -.50 X -3.75 X 9, LEFT EYE PRE-OP 20/20 .00 X -4.00 X 178. BCVA FROM (B)(6) 2018: RIGHT EYE POST-OP 20/20 .00 X .00 X 90, LEFT EYE POST-OP 20/20 .25 X -.25 X 125.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417759 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention WAVELIGHT SERIAL NO. (B)(4)