BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX AQUA

    MDR report key: 2190871 · Received July 28, 2011

    Report

    Report Number
    9681121-2011-00025
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 28, 2011
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT LENS WAS DISCARDED AND THE UNOPENED LENSES HAVE NOT BEEN REC'D FOR EVAL. THE AFFECTED LOT NUMBER OF THE LENS IS UNK THEREFORE NO MFG INVESTIGATION COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CORNEAL ULCER IN THE RIGHT EYE. THE OPHTHALMOLOGIST REPORTED PT'S EYE WAS PRESENTED WITH REDNESS, PAIN, PHOTOPHOBIA AND LID SWELLING OF 2 DAYS DURATION. EXAMINATION REVEALED CORNEAL ULCER WAS 1-2MM IN SIZE, CENTRAL IN LOCATION, 1MM INFILTRATE, AND DUSTING OF WBCS ON THE ENDOTHELIUM. OPHTHALMOLOGIST PRESCRIBED CONCENTRATED ANTIBIOTICS EVERY 15 MINS. F/U WITH MEDICAL RECORDS REVEALED THE CORNEAL ULCER IS RESOLVING AND THE PT'S VISUAL ACUITY HAS BEEN REALLY GOOD. THE PT HAS NOT RESUMED CONTACT LENS WEAR AND IS WEARING GLASSES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention