BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE

    MDR report key: 4101644 · Received August 27, 2014

    Report

    Report Number
    8020392-2014-00007
    Event Type
    Injury
    Date Received
    August 27, 2014
    Report Date
    July 30, 2014
    Manufacturer
    CIBA VISION CANADA, INC.
    Product Code
    LPN
    PMA / PMN Number
    K031521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVAL. THE LOT NUMBER IS UNK. A TREND RELATED INVESTIGATION IS CURRENTLY IN PROCESS. UPON COMPLETION, A FOLLOW UP MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT/CONSUMER EXPERIENCED "TRANSIENT BLINDNESS, CHEMICAL BURNS OF EYE, EYE IRRITATION, BLURRED VISION, WRONG TECHNIQUE IN DRUG USAGE PROCESS." IT IS NOTED THAT THE ISSUE RESOLVED. NO OTHER INFO WAS PROVIDED. ADD'L INFO IS NOT AVAILABLE SINCE THE REPORTER'S CONTACT INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522697 CLEAR CARE LENS ACCESSORIES LPN CIBA VISION CANADA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other