BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES FRESHLOOK ILLUMINATE

    MDR report key: 2489262 · Received March 9, 2012

    Report

    Report Number
    9610813-2012-00002
    Event Type
    Injury
    Date Received
    March 9, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 10, 2012
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS INITIALLY REPORTED BY THE PT THAT THEY EXPERIENCED IRRITATION IN ASSOCIATION WITH CONTACT LENS WEAR. ADDITIONAL INFO RECEIVED STATED THAT THE PT DEVELOPED A CORNEAL ULCER AND INFILTRATE. ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT IS BEING REPORTED DUE TO LACK OF INFO RECEIVED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILIES FRESHLOOK ILLUMINATE LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH N0215939

    Patients

    Seq Age Sex Outcome Treatment
    1 Other