BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX AQUA

    MDR report key: 2182431 · Received July 22, 2011

    Report

    Report Number
    3006186389-2011-00012
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CIBA VISION JOHORE SDN.BHD
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING INVESTIGATION OF THE AFFECTED LOT REVEALED THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MFG PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. MFG AND STERILITY RECORDS ARE IN COMPLIANCE AND SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS ON TWO DIFFERENT LOTS INVOLVING THE SAME EVENT FOR THE SAME PT. TWO REPORTS ARE REQUIRED DUE TO THE INABILITY TO DETERMINE WHICH OF THE REPORTED LOTS WAS SPECIFICALLY INVOLVED IN THE EVENT. REFER TO MEDWATCH 3006186389-2011-00011 FOR THE FIRST REPORT ON THE ALTERNATE LOT REPORTED. AN EYE CARE PROFESSIONAL REPORTED THAT A CONTACT LENS WEARER EXPERIENCED A CORNEAL ULCER, LEFT EYE (EXACT LOCATION OF ULCER IN THE EYE UNK) ASSOCIATED WITH WEAR OF AIR OPTIX AQUA CONTACT LENSES. ACCORDING TO THE MEDICAL REPORT RECEIVED, THE PT ATTENDED AN OPHTHALMOLOGIST DUE TO TEARING, PHOTOPHOBIA AND A FOREIGN BODY SENSATION, LEFT EYE. INTRAOCULAR PRESSURE WAS REPORTED TO BE "OK", NO FOREIGN PARTICLES NOTED, BUT EXHIBITED A CENTRAL CORNEAL EROSION. CORNEAL ULCER DIAGNOSED. TREATMENT CONSISTED OF '(B)(6) EYE CREAM' AND OCCLUSION FOR 48 HOURS. F/U INFO RECEIVED (B)(6) 2011 INDICATED THAT EVENT RESOLUTION NOTED AT (B)(6) 2011 VISIT, VISUAL ACUITY RETURNED TO NORMAL AND LENS WEAR HAS RESUMED WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX AQUA LENSES, SOFT CONTACT, EXTENDED WEAR LPM CIBA VISION JOHORE SDN.BHD 10106747201512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other