BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7489581 · Received May 6, 2018

    Report

    Report Number
    3006695864-2018-01017
    Event Type
    Injury
    Date Received
    May 6, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 6, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 TRANSIENT LIGHT SENSITIVITY, SOME DRYNESS AND WATERY EYES(OU) POST TREATMENT. THE RIGHT EYE WAS NOTED TO BE MORE WATERY THAN THE LEFT 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 VISION NOT AS CLEAR DUE TO EYES BEING UNCOMFORTABLE. THE PATIENT REPORTED THE SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. THE PATIENT HAS BEGUN LOTEMAX AND THEN TO BE TAPERED OFF. BCVA FROM (B)(6) 2017: RIGHT EYE PRE-OP 20/20 -6.50X -1.25 X 0, LEFT EYE PRE-OP 20/20 -6.00 X -1.00 X 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332106 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention