BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AOSEPT CLEAR CARE CLEANING AND DISINFECTANT

    MDR report key: 1901580 · Received November 12, 2010

    Report

    Report Number
    8020392-2010-00020
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    October 15, 2010
    Manufacturer
    CIBA VISION CANADA, INC.
    Product Code
    LPN
    PMA / PMN Number
    K030522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A F/U MEDWATCH WILL BE FILED. INTERNAL CONTROL NUMBER: (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSUMER WAS TOLD THAT HER DOCTOR WAS CONCERNED THAT SHE MAY HAVE BURNED HER CORNEA FOLLOWING USE OF THE LENS CARE PRODUCT TO CLEAN HER CONTACT LENSES. THE CONSUMER WAS EXAMINED BY AN EYE SPECIALIST. DESCRIPTION OF THE TREATMENT OF THE CONSUMER WAS NOT PROVIDED. ADD'L INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED. UPON RECEIPT OF ADD'L INFO, IF THERE IS ANY FURTHER RELEVANT INFO, A F/U REPORT WILL BE FILED. THIS EVENT IS BEING REPORTED DUE TO THE LACK OF INFO RECEIVED REGARDING THE PT'S DIAGNOSIS, TREATMENT, AND EVENT RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AOSEPT CLEAR CARE CLEANING AND DISINFECTANT LENS ACCESSORIES LPN CIBA VISION CANADA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention