BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES FRESHLOOK ILLUMINATE

    MDR report key: 2848997 · Received November 15, 2012

    Report

    Report Number
    9610813-2012-00016
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    September 4, 2012
    Report Date
    October 18, 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 US. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT FRESHLOOK ONE-DAY THAT IS SOLD IN THE US UNDER PMA/510 (K) # K050213. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE LOT NUMBER IS UNK, 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 WAS REPORTED BY A HEALTH AUTHORITY THAT A PT EXPERIENCED PAIN ON (B)(6) 2012 AFTER THE LENSES HAD BEEN IN THE EYES FROM (B)(6) 2012. IT IS NOTED THAT THE PT HAD PURCHASED THE CONTACT LENSES ON THE INTERNET, BUT DID NOT VISIT A DOCTOR. THE PT THEN VISITED A DOCTOR ON (B)(6) 2012 AND WAS DIAGNOSED WITH BACTERIAL CORNEAL INFILTRATES IN THE RIGHT EYE. RECEIVED F/U INFO ON (B)(6) 2012 WHICH STATES, ON (B)(6) 2012, THE PT FELT PAIN (UNSPECIFIED SEVERITY) AND WATERY EYE AFTER TWO DAYS OF EXTENDED WEAR. ON (B)(6) 2012, THE PT VISITED THE OPHTHALMOLOGIST AND WAS DIAGNOSED WITH BACTERIAL CORNEAL INFILTRATION. ON (B)(6) 2012, THE INFILTRATION SHOWED THE TREND OF RECOVERY. PT WAS SCHEDULED TO RETURN FOR F/U ON (B)(6) 2012, HOWEVER THE PT DID NOT RETURN FOR CONSULTATION. THERE IS NO ULCER AND THE CORNEAL INFILTRATION IS THREE POINTS IN THE UPPER PART OF THE VISUAL AXIS AND TWO POINTS IN THE PERIPHERAL AT 12 O'CLOCK. THE TREATMENT WAS VEGAMOX (MFLX) EYE DROP EVERY HOUR ON (B)(6) 2012, AND FIVE TIMES A DAY ON (B)(6) 2012. THE VISUAL ACUITY PRIOR TO THE SYMPTOMS IS UNK, BUT THE VISUAL ACUITY AFTER THE SYMPTOMS IN THE RIGHT EYE WAS 0.6 (UNCORRECTED VISION, WHILE IN THE LEFT EYE THE VISUAL ACUITY IS 0.4.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other