BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX AQUA

    MDR report key: 3649938 · Received February 10, 2014

    Report

    Report Number
    3006186389-2014-00002
    Event Type
    Injury
    Date Received
    February 10, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 14, 2014
    Manufacturer
    CIBA VISION JOHOR SDN.BHD.
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A FOLLOW-UP MEDWATCH WILL BE FILED. INTERNAL CONTROL NUMBER: 212793.

    Description of Event or Problem · 1

    A REPORT OF EPITHELIAL LOSS, ASSOCIATED WITH THE EXTENDED USE OF A CONTACT LENS, WAS RECEIVED FROM A CONSUMER. MEDICAL ATTENTION WAS SOUGHT FROM AN URGENT CARE CLINIC AFTER THE PT AWOKE WITH PAIN THAT EVOLVED FROM A MILD DISCOMFORT TO SEVERE PAIN IN THE LEFT EYE. THE URGENT CARE STAFF COULD NOT DETERMINE THAT ANYTHING WAS WRONG AND THE PT RETURNED HOME. THE SAME NIGHT, THE PAIN BECAME MORE INTENSE AND THE NEXT DAY, THE PT VISITED THE EMERGENCY ROOM WHERE SHE WAS TOLD THAT AS A RESULT OF WEARING THE LENS AS EXTENDED WEAR, THE LENS DEHYDRATED ON THE EYE AND REMOVED THE TOP LAYER OF THE CORNEA, EXPOSING THE NERVES. FURTHER INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86609 AIR OPTIX AQUA LENSES, SOFT CONTACT, EXTENDED WEAR LPM CIBA VISION JOHOR SDN.BHD. 10147625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention