BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX FOR ASTIGMATISM

    MDR report key: 2103786 · Received May 24, 2011

    Report

    Report Number
    9681121-2011-00017
    Event Type
    Injury
    Date Received
    May 24, 2011
    Report Date
    April 26, 2011
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON 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. (B)(4).

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS ON THE SAME PATIENT INVOLVING TWO PRODUCTS. REFER TO MEDWATCH 9681121-2011-00018 FOR A DESCRIPTION OF THE SECOND EVENT. AN EYE CARE PROFESSIONAL (ECP) REPORTED THAT A PATIENT EXPERIENCED ULCERS IN BOTH EYES. THE PATIENT EXPERIENCED SEVERE PAIN, MODERATE REDNESS, AND WATERY, MUCOPURULENT DISCHARGE. THE ECP TREATED WITH BESIVANCE ONE DROP THREE TIMES A DAY. THE REPORTING ECP DID NOT KNOW THE EVENT RESOLUTION OF THE PATIENT AS THE PATIENT WENT TO ANOTHER OPHTHALMOLOGIST. THIS EVENT IS BEING REPORTED DUE TO LACK OF INFORMATION RECEIVED REGARDING THE PATIENT'S TREATMENT AND EVENT RESOLUTION. THIS EVENT IS BEING REPORTED DUE TO LACK OF INFORMATION RECEIVED REGARDING THE PATIENT'S TREATMENT AND EVENT RESOLUTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. UPON RECEIPT OF ADDITIONAL INFORMATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT LPM PT. CIBA VISION BATAM 3100461

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other