BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AOSEPT PLUS/CLEAR CARE

    MDR report key: 2003939 · Received February 24, 2011

    Report

    Report Number
    8020392-2011-00003
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    August 24, 2006
    Report Date
    August 25, 2006
    Manufacturer
    CIBA VISION STERILE MANUFACTURING
    Product Code
    LPN
    PMA / PMN Number
    K030522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER RETURNED TO THE ECP'S OFFICE ON (B)(6) 2006, SHE WAS TREATED FOR POST ABRASION AND WAS TOLD TO CONTINUE ANTIBIOTIC AND STEROID COMBINATION DROP QID. THE CONSUMER RETURNED TO THE ECP'S OFFICE ON (B)(6) 2006, IT WAS NOTED THAT THE ABRASION IN THE LEFT EYE WAS HEALED AND MILD KERATITIS WAS OBSERVED. THE CONSUMER RETURNED TO THE ECP'S OFFICE ON (B)(6) 2006, POST CHEMICAL PEK, MAP DOT FINGERPRINT DYSTROPHY (MDF) AND CATARACTS WERE NOTED. IT WAS INDICATED THE CONSUMER CAN RETURN TO CONTACT LENS WEAR. ON (B)(6) 2006, THE FOLLOW UP STATUS POST CHEMICAL PEK SECONDARY TO CONTACT LENS SOLUTION, CORNEAL SCAR OD, EPI-RETINAL MEMBRANE WERE NOTED AT THIS VISIT. ON THE (B)(6) 2006 VISIT, THE CHEMICAL PEK WAS RESOLVED. THE ECP TOLD THE PT THAT THE EROSION IS NOT RELATED TO THE H2O2 INJURY. THE CONTACT LENS SOLUTION WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE SOLUTION WAS NOTED TO BE IN-SPECIFICATION AND THE AOCUP WAS NOTED TO BE OUT OF SPECIFICATION. THE DEVICE HISTORY AND STERILITY RECORDS HAVE BEEN REVIEWED BY MANUFACTURING AND FOUND TO BE IN COMPLIANCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY A CONSUMER ON (B)(6) 2006 THAT SHE EXPERIENCED BURNING UPON USE OF AOSEPT PLUS/CLEAR CARE. ON (B)(6) 2011, THE SAME CONSUMER REPORTED THAT SHE HAS A SCAR ON HER RIGHT EYE (OD) CAUSED WHEN SHE REMOVED HER LENS AFTER EXPERIENCING BURNING/STINGING WITH AOSEPT PLUS/CLEAR CARE. ADDITIONAL INFORMATION ON (B)(6) 2011, FROM EYE CARE PROFESSIONAL (ECP) STATED THE CONSUMER PRESENTED AT HIS OFFICE ON (B)(6) 2006, WITH MILD EDEMA, HYPEREMIA AND MILD PUNCTATE EPITHELIAL KERATITIS (PEK) IN BOTH EYES (OU). SHE WAS PRESCRIBED A STEROID DROP AND A NONSTEROIDAL ANTI-INFLAMMATORY DROP. THE CONSUMER RETURNED TO THE ECP'S OFFICE ON (B)(6) 2006 AND (B)(6) 2006, SHE WAS DIAGNOSED WITH CHEMICAL ABRASION. THE CONSUMER RETURNED TO THE ECP'S OFFICE ON (B)(6) 2006, SHE WAS DIAGNOSED WITH CHEMICAL ABRASION AND EPITHELIAL DEGENERATION. THE CONSUMER RETURNED TO THE ECP'S OFFICE ON (B)(6) 2006, IT WAS NOTED THE ABRASION HEALED AND WAS PRESCRIBED AN ANTIBIOTIC AND STEROID COMBINATION DROP FOUR TIMES DAILY (QID) AND ARTIFICIAL TEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AOSEPT PLUS/CLEAR CARE ACCESSORIES, SOFT LENS PRODUCTS LPN CIBA VISION STERILE MANUFACTURING 48487

    Patients

    Seq Age Sex Outcome Treatment
    1 Other