BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 1940464 · Received December 20, 2010

    Report

    Report Number
    9681121-2010-00053
    Event Type
    Injury
    Date Received
    December 20, 2010
    Report Date
    December 6, 2010
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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 F/U MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EYECARE PROFESSIONAL THAT A PT EXPERIENCED MODERATE PAIN AND REDNESS, MILD CORNEAL STAINING, AN UNK QUANTITY OF CENTRAL INFILTRATES, AND A LARGE CENTRAL CORNEAL ULCER IN THE LEFT EYE DUE TO EYE CONTACT LENS ABUSE. THE PT HAS A PRE-EXISTING CONDITION OF CORNEAL HYPOXIA. THE PT WAS TREATED WITH ZYMAR. THE PT WAS SCHEDULED FOR A F/U EXAM VISIT ON (B)(6) 2010, HOWEVER, SHE CANCELED AND HAS NOT RESCHEDULED THE APPT. IT IS UNK IF THE ISSUE HAS RESOLVED AND IF CONTACT LENS WEAR HAS RESUMED. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED. UPON RECEIPT OF ADDITIONAL INFO, IF THERE IS ANY FURTHER RELEVANT INFO, A F/U 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention