BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AOSEPT PLUS

    MDR report key: 3111183 · Received May 8, 2013

    Report

    Report Number
    8020392-2013-00002
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CIBA VISION CANADA, INC.
    Product Code
    LPN
    PMA / PMN Number
    K031521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY AN EYE CARE PROFESSIONAL THAT A PATIENT USED THE LENS CARE SOLUTION ACCORDING TO THE PRESCRIBING PHARMACY'S INSTRUCTIONS AND HAS EXPERIENCED BURNING AND STINGING TO HIS EYES. THE PATIENT VISITED THE HOSPITAL AND THE DOCTOR STATED THAT HE HAS EXPERIENCED CHEMICAL BURNS AND WILL NO LONGER BE ABLE TO WEAR CONTACT LENSES. ADDITIONAL INFORMATION RECEIVED FROM THE EYE CARE PROFESSIONAL ON (B)(6) 2013, STATED THAT THE PATIENT WAS CURRENTLY WEARING A BANDAGE CONTACT LENS FOR SEVEN DAYS. ADDITIONAL INFORMATION RECEIVED FROM THE EYE CARE PROFESSIONAL ON (B)(6) 2013, STATED THAT THE PATIENT ACCIDENTALLY PUT THE LENS CARE SOLUTION DIRECTLY ONTO HIS CONTACT AND THEN THE CONTACT INTO HIS EYES. "THE BOY HAS HAD A FOLLOW UP APPOINTMENT WITH THE HOSPITAL (B)(6) 2013 AND IT HAS COME TO LIGHT THAT HE HAS MISUSED THE SOLUTION. HE CLEANED FLUFF FROM THE LENS WITH NEAT SOLUTION AS HE WOULD WITH A ONE STEP PRODUCT, HE THEN REINSERTED THE LENSES." ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S FATHER ON (B)(6) 2013, STATES THAT HIS SON HAS FULLY RECOVERED AND HAS RESUMED LENS WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202163 AOSEPT PLUS LENS ACCESSORIES LPN CIBA VISION CANADA, INC. Z0006990

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other