BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES FRESHLOOK ILLUMINATE

    MDR report key: 6797881 · Received August 16, 2017

    Report

    Report Number
    9610813-2017-00018
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    July 20, 2017
    Report Date
    August 16, 2017
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K050213
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. NO MANUFACTURING REVIEW WAS INDICATED. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. PMA 5610(K): THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT FRESHLOOK ONE-DAY THAT IS SOLD IN THE UNITED STATES UNDER PMA/510(K) # K050213. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY AN OPHTHALMOLOGIST VIA FAX ON (B)(6)2017, A FEMALE PATIENT PREVIOUSLY EXPERIENCED IRRITATION AFTER WEARING THE LENS. IT WAS INDICATED THAT THE PATIENT VISITED THE DOCTOR ON (B)(6)2017 AND WAS DIAGNOSED WITH CORNEAL ULCER. THE PATIENT WAS PRESCRIBED CRAVIT EYE DROPS 4 TIMES DAILY AND WAS ADVISED TO STOP WEARING CONTACT LENSES AND TO WEAR AN EYE BANDAGE. AT THE TIME OF THIS REPORT, THE PATIENT'S CONDITION HAS CONTINUED. NO ADDITIONAL INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578894 DAILIES FRESHLOOK ILLUMINATE NA MVN CIBA VISION GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other