BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX AQUA

    MDR report key: 3072338 · Received April 18, 2013

    Report

    Report Number
    3006186389-2013-00003
    Event Type
    Injury
    Date Received
    April 18, 2013
    Report Date
    March 26, 2013
    Manufacturer
    CIBA VISION JOHOR SDN.BHD.
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVAL. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN EYE CARE PROVIDER (ECP) THAT A PT DEVELOPED A PERIPHERAL ULCER DURING CONTACT LENS WEAR. THE PT WAS SWITCHED TO ANOTHER MFR'S LENSES AND LENS CARE SOLUTION. THE ULCER HAS RESOLVED. ADDITIONAL DETAILED INFORMATION REGARDING THE EVENT WAS REQUESTED BUT HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168266 AIR OPTIX AQUA LENSES, SOFT CONTACTS, EXTENDED WEAR LPM CIBA VISION JOHOR SDN.BHD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention