BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT AND DAY AQUA

    MDR report key: 3213575 · Received July 3, 2013

    Report

    Report Number
    9681121-2013-00007
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 12, 2013
    Manufacturer
    CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 EVALUATION. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A FOLLOW-UP MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    A REPORT OF A CORNEAL ULCER ASSOCIATED WITH THE AIR OPTIX NIGHT AND DAY AQUA LENS WAS REC'D FROM AN EYE CARE PROFESSIONAL. A PT, WHO WEARS THE LENS FOR 30 DAYS EXTENDED WEAR, VISITED AN EMERGENCY ROOM AND WAS GIVEN AN UNK OINTMENT FOR AN UNSPECIFIED REASON. THE LENS HAD BEEN IN THE EYE FOR ALMOST A MONTH AT THE TIME OF THE EVENT. THE PT PRESENTED THE NEXT DAY IN THE EYE CARE PROFESSIONAL'S OFFICE AND A CORNEAL ULCER WAS DIAGNOSED. THE ULCER WAS TWO (2) MILLIMETER IN SIZE AND LOCATED MID PERIPHERALLY. THE ULCER DID NOT PRESENT WITH A STANDARD APPEARANCE AND WAS NOTED AS "DEEP" LOOKING. AN OINTMENT WAS PROVIDED AND THE PT WAS REFERRED TO A SPECIALIST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305971 AIR OPTIX NIGHT AND DAY AQUA LENSES, SOFT CONTACTS, EXTENDED WEAR LPM CIBA VISION BATAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention