BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 2686644 · Received August 3, 2012

    Report

    Report Number
    9610813-2012-00010
    Event Type
    Injury
    Date Received
    August 3, 2012
    Report Date
    July 6, 2012
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DAILIES VISITINT AQUACOMFORT PLUS THAT IS SOLD IN THE UNITED STATES UNDER PMA/510(K) #K984273. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN EYE CARE PROFESSIONAL THAT A PT DEVELOPED A PERIPHERAL INFECTIOUS CORNEAL ULCER IN HER LEFT EYE FOLLOWING CONTACT LENS WEAR. ACCORDING TO THE DIAGNOSING OPHTHALMOLOGIST, "THE CONTACT LENS IS NOT THE REASON OF THE INFECTIOUS ULCER". THE PT IS "ON THE ROAD FOR BEING RESOLVED". THE OPHTHALMOLOGIST DID NOT KNOW WHEN HE WOULD CHECK THE PT'S EYE AGAIN. THE PT WAS TREATED WITH 15 DAYS OF ANTIBIOTIC TREATMENT: PHYLARM SOLUTION, GENTALLINE COLLYRE, TOBREX COLLYRE. ON THE SAME DAY AFTER THE CONSULTATION, THE PT HAD A CONJUNCTIVAL TAKING AND NO PATHOGENIC GERMS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) LPL CIBA VISION GMBH N1104007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other