BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUIFY MULTIPURPOSE SOLUTION

    MDR report key: 1071316 · Received July 8, 2008

    Report

    Report Number
    8020392-2008-00006
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 13, 2008
    Manufacturer
    CIBA VISION CANADA, INC. STERILE MFG (CVSM)
    Product Code
    LPN
    PMA / PMN Number
    K050250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS REVIEWED BY THE CIBA VISION MEDICAL MONITOR WITH THE FOLLOWING CONCLUSION: "THIS CASE IS CONSIDERED AS A POSSIBLE INFECTIOUS CORNEAL ULCER." A MFG INVESTIGATION IS UNDERWAY. IF ANY ABNORMALITY IS FOUND, A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN EYE CARE PROFESSIONAL REPORTED THAT AN UNSPECIFIED PT EXPERIENCED DISCOMFORT AND REDNESS AFTER CHANGING THE LEFT CONTACT LENS IN 2008. THE PAIN LEVEL INCREASED DESPITE REMOVING THE LENS. CILOXAN, RIFAMICINE AND DESORGAMINE WERE PRESCRIBED FOR TREATMENT OF A CORNEAL ABSCESS/ULCER, LOCATED PARA-CENTRAL CORNEA, ABOUT TWO DAYS LATER, AT AN EMERGENCY ROOM. A RISK OF INFECTION TO THE FELLOW EYE WAS NOTED. O2OPTIX FOR ASTIGMATISM CONTACT LENS WAS IN USE AT THE TIME OF EVENT. THE LENS CASE WAS CULTURED POSITIVE FOR SERRATIA MARSCENS. NO PRE OR POST EVENT VISUAL ACUITY HAS BEEN PROVIDED. SCARRING IS EXPECTED. REQUEST HAS BEEN MADE FOR ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUIFY MULTIPURPOSE SOLUTION LENS CARE SOLUTION LPN CIBA VISION CANADA, INC. STERILE MFG (CVSM) NA 06108388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED