BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX AQUA MULTIFOCAL

    MDR report key: 1870804 · Received October 11, 2010

    Report

    Report Number
    9681121-2010-00034
    Event Type
    Injury
    Date Received
    October 11, 2010
    Report Date
    September 11, 2010
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. INTERNAL CONTROL NUMBER: (B)(4).

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS ON THE SAME EVENT INVOLVING TWO PRODUCTS. REFER TO MEDWATCH 8020392-2010-00014 FOR A DESCRIPTION OF THE SECOND REPORT. IT WAS REPORTED BY THE PT'S MOTHER THAT HER DAUGHTER EXPERIENCED CORNEAL ULCER, INFECTION, AND SCARRING FOLLOWING HER USE WITH (B)(4) AND WAS TREATED IN THE EMERGENCY ROOM. FOLLOW-UP INFO FROM THE PT'S EYE CARE PROVIDER STATED THE PT WAS USING (B)(4) FOR HER LENS CARE PRODUCT. THE PT DID NOT SHOW UP FOR HER FOLLOW-UP APPOINTMENT WITH THE EYE CARE PROVIDER OR RESCHEDULE THE APPOINTMENT WHEN SHE WAS CALLED. ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX AQUA MULTIFOCAL LENSES, SOFT CONTACT, EXTENDED WEAR LPM PT. CIBA VISION BATAM 10029695

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention