BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILTES FRESHLOOK ILLUMINATE

    MDR report key: 2864397 · Received December 6, 2012

    Report

    Report Number
    9610813-2012-00017
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    July 26, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 BASE ON A SIMILAR PRODUCT FRESHLOOK ONE-DAY THAT IS SOLD IN THE UNITED STATES UNDER PMA/SLO (K) # K050213. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE LOT NUMBER IS UNKNOWN, THEREFORE FURTHER INVESTIGATION CANNOT BE PERFORMED. A TREND RELATED INVESTIGATION WAS PERFORMED. NO TREND COULD BE IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED BY THE (B)(6) THAT ON (B)(6)2012, THE PATIENT HAD RED EYE AND VISITED THE DOCTOR. THE PATIENT WAS DIAGNOSED WITH A CORNEAL ULCER IN THE RIGHT EYE (OD). THE DOCTOR PRESCRIBED UNSPECIFIED EYE DROPS (TYPE UNKNOWN). RECEIVED FOLLOW UP INFORMATION ON (B)(6) 2012 WHICH STATES THE PATIENT EXPERIENCED PAIN AND REDNESS IN THE RIGHT EYE ON THE MORNING OF (B)(6) 2012 AND VISITED AND OPHTHALMOLOGIST. THE OPHTHALMOLOGIST CONFIRMED THAT THE PATIENT HAD A PERIPHERAL CORNEAL ULCER AT THE 1 O'CLOCK POSITION. THE PATIENT WAS INSTRUCTED TO RETURN THE NEXT DAY FOR FOLLOW UP, HOWEVER THE PATIENT DID NOT SHOW UP. THE PATIENT HAS NOT CONSULTED WITH THE DOCTOR AFTER THE INITIAL VISIT. IT IS NOTED THAT THE OPHTHALMOLOGIST JUDGED THAT THIS ULCER WAS NON-SERIOUS AND THA THE SYMPTOMS ARE COMMON DUE TO WEAR OF THE CONTACT LENSES. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILTES FRESHLOOK ILLUMINATE LENSES, SOFT CONTACT, DAILY WEAR MVN CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other