BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 1970336 · Received January 14, 2011

    Report

    Report Number
    9681121-2011-00001
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 17, 2010
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THE COMPLAINT PRODUCT WAS NOT RETURNED AND RETAIN SAMPLES WERE NOT AVAILABLE IN INVENTORY FOR EVALUATION. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EYECARE PROFESSIONAL THAT A PATIENT PRESENTED AT THE OFFICE AND WAS DIAGNOSED WITH A CORNEAL ULCER IN THE RIGHT EYE. THE PATIENT WAS TREATED WITH CYCLOPLEGIC AND ZYMAXID. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP EXAM VISIT ON (B)(6) 2010. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010, FROM THE EYECARE PROFESSIONAL INDICATED, THAT THE ULCER WAS LOCATED IN THE UPPER TOP OF THE CORNEA. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN IF THE TISSUE HAS RESOLVED AND IF CONTACT LENS WEAR HAS RESUMED. 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 NIGHT & DAY AQUA LENSES, SOFT CONTACT, EXTENDED WEAR LPM PT CIBA VISION BATAM 9682045

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention