BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUIFY MPS

    MDR report key: 4101646 · Received August 27, 2014

    Report

    Report Number
    8020392-2014-00010
    Event Type
    Injury
    Date Received
    August 27, 2014
    Report Date
    August 1, 2014
    Manufacturer
    CIBA VISION CANADA, INC.
    Product Code
    LPN
    PMA / PMN Number
    K05250
    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

    AS REPORTED IN AN OPHTHALMOLOGY PERIODICAL (ARCH OPHTHALMOL/VOL 127 (NO. 12). DEC 2009, PAGES 1616-1623), A CASE REPORT IS REFERENCED WHICH INVOLVES A CASE OF MICROBIAL KERATITIS. NO OTHER INFO WAS PROVIDED. DUE TO THE SOURCE OF THE COMPLAINT, FURTHER INFO AND FOLLOW UP IS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522676 AQUIFY MPS LENS ACCESSORIES LPN CIBA VISION CANADA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other