BEUDAMED
    FDA Adverse Event Summary report: N

    DAILIES TOTAL 1

    MDR report key: 2960316 · Received February 8, 2013

    Report

    Report Number
    9610813-2013-00003
    Date Received
    February 8, 2013
    Report Date
    January 10, 2013
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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) # K072777. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED.(B)(6).

    Description of Event or Problem · 1

    THIS IS SECOND OF TWO REPORTS FOR THE SAME PT INVOLVING TWO LOT NUMBERS OF THE SAME PRODUCT. IT IS UNKNOWN WHICH LOT NUMBER WAS USED IN WHICH EYE. REFER TO 9610813-2013-00002, FOR DESCRIPTION OF THE FIRST REPORT. IT IS INITIALLY REPORTED FROM AN EYE CARE PROFESSIONAL THAT A PT, WHO HAD BEEN EXPERIENCING PROBLEMS WITH CONTACT LENSES, WENT TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH CORNEAL INFILTRATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 FROM THE PT'S EYE CARE PROFESSIONAL STATES THAT THE CONSUMER IS ABLE TO RESUME CONTACT LENS WEAR IN 10 DAYS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013, FROM THE PT STATES THAT HER LAST EXAMINATION WAS ON (B)(6) 2012. SHE STATES THAT SHE HAS BEEN WEARING CONTACT LENSES FOR 37 YEARS, AND STARTED WITH HARD LENSES. SHE SWITCHED TO THIS BRAND OF CONTACT LENSES SIX YEARS AGO. NOW SHE IS ONLY USING XILOIAL FORTE EYEWASH WHEN SHE HAS SENSATION OF DRY EYE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013, STATES THAT THE PT HAS NOT RESUMED LENS WEAR YET AND DOES NOT HAVE A FOLLOW-UP EXAMINATION SCHEDULED SINCE HER LAST ONE DATED (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53419 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH N1102399

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other