BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ADVANCE WITH HYDRACLEAR

    MDR report key: 2010793 · Received March 2, 2011

    Report

    Report Number
    1033553-2011-00017
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 2, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW OF THE PRODUCT IN QUESTION INDICATED: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. FOUR SEALED BLISTERS AND ONE LENS IN A LENS CASE WERE RETURNED. THE PARAMETERS OF THE SUSPECT LENS WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENS MET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. NO VISUAL ATTRIBUTES WERE OBSERVED. NO ADDITIONAL INFORMATION IS EXPECTED TO BE RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM OUR (B)(4) AFFILIATE. ON (B)(6) 2011, A PATIENT WHO WORE ACUVUE ADVANCE WITH HYDRACLEAR CONTACT LENSES CONTACTED THE JOHNSON & JOHNSON VISIONCARE AFFILIATE IN (B)(4) AND REPORTED EXPERIENCING A MEDICAL ADVERSE EVENT SEVERAL DAYS INTO HIS/HER WEAR SCHEDULE. THE PATIENT REPORTED EXPERIENCING FOREIGN BODY SENSATION AND PAIN IN THE LEFT EYE (OS). THE PATIENT CONSULTED AN EYE CARE PROFESSIONAL (ECP) AT AN EYE CLINIC. THE PATIENT STATED THAT THE ECP NOTED STAINING, DIFFUSE SUPERFICIAL KERATITIS AND UVEITIS OS. THE PATIENT WAS PRESCRIBED CRAVIT 0.5% AND HYALEIN 0.1% EYE DROPS. ON (B)(6) 2011, OUR (B)(4) AFFILIATE CONTACTED THE CLINIC FOR A MEDICAL INTERVIEW. THE OFFICE CLERK PROVIDED ADDITIONAL INFORMATION BASED ON THE PATIENT'S MEDICAL RECORD AND CONFIRMED THAT THE PATIENT INITIALLY PRESENTED ON (B)(6) 2011. THE OFFICE CLERK ALSO CONFIRMED THE PATIENT'S DIAGNOSIS, TREATMENT AND THAT THE PATIENT'S VISUAL ACUITY WAS MEASURED AND FOUND NOT TO BE AFFECTED. ON (B)(6) 2011, THE PATIENT RETURNED TO THE CLINIC FOR A FOLLOW UP. THE PATIENT'S STAINING IN THE OS HAD COMPLETELY RESOLVED. THE PATIENT WAS GIVEN NO EYE DROPS. THE PATIENT WAS ALLOWED TO RESUME CL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE ADVANCE WITH HYDRACLEAR SOFT CONTACT LENS LPL VISTAKON NA L001G2S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention