BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AOSEPT PLUS

    MDR report key: 4122313 · Received September 18, 2014

    Report

    Report Number
    8020392-2014-00013
    Event Type
    Injury
    Date Received
    September 18, 2014
    Report Date
    August 22, 2014
    Manufacturer
    CIBA VISION CANADA, INC.
    Product Code
    LPN
    PMA / PMN Number
    K031521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    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 IS CURRENTLY IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE FILED UPON COMPLETION OF THE TREND INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT ON (B)(6) 2014, THE REQUIRED CUP WAS NOT UTILIZED FOR CLEANING THE CONTACT LENSES, WHICH RESULTED IN PAIN AND RED EYE. FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2014 FROM THE PATIENT'S SISTER STATES THAT THE PATIENT CONSULTED A PHYSICIAN ON THAT DAY AND WAS DIAGNOSED WITH A CHEMICAL BURN. THE PHYSICIAN PRESCRIBED AN UNKNOWN EYE DROP FOR SEVERAL DAYS AND INSTRUCTED THE PATIENT TO RETURN TO THE OFFICE ON (B)(6) 2014. A FOLLOW-UP ATTEMPT TO INQUIRE ON THE PATIENT'S STATUS WAS MADE ON (B)(6) 2014: IT WAS NOTED THAT NO FURTHER INFORMATION WAS AVAILABLE FOR THE CHEMICAL BURN, AND ALSO THAT THE PATIENT ALSO STATED THAT SHE HAD A MISCARRIAGE AFTER THIS REPORTED EVENT OCCURRED THINKS IT WAS DUE TO THE STRESS OF THE EVENT. FURTHER INFORMATION RECEIVED ON 8/26/2014 STATES THAT THE PATIENT RETURNED FOR THE PREVIOUSLY SCHEDULED FOLLOW-UP WITH THE TREATING EYE-CARE PHYSICIAN ON (B)(6) 2014 AND WAS TOLD BY THE PHYSICIAN THAT THE CHEMICAL BURN HAD NOT YET RESOLVED. THE PATIENT WAS PRESCRIBED AN UNSPECIFIED MOISTURE AGENT, A CEASE IN CONTACT LENS WEAR FOR ONE WEEK, AND INSTRUCTED TO RETURN FOR FOLLOW-UP IN ONE WEEK. ON (B)(6) 2014, A FOLLOW-UP ATTEMPT WAS MADE TO THE PATIENT TO OBTAIN FURTHER INFORMATION REGARDING THE REPORTED MEDICAL EVENTS, BUT THIS REQUEST WAS REFUSED BY THE PATIENT'S HUSBAND. ADDITIONAL CLARIFYING INFORMATION RECEIVED ON 8/27/2014 CONFIRMS THE COLLECTION OF THE INFORMATION REGARDING THE REPORT OF MISCARRIAGE FROM THE PATIENT; THE PATIENT STATED THAT SHE ATTRIBUTED THE MISCARRIAGE TO STRESS ASSOCIATED WITH THE REPORTED MISUSE OF THE PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579134 AOSEPT PLUS LENS ACCESSORIES LPN CIBA VISION CANADA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other