BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ADVANCE PLUS BRAND CONTACT LENSES

    MDR report key: 3231424 · Received July 15, 2013

    Report

    Report Number
    1033553-2013-00089
    Event Type
    Injury
    Date Received
    July 15, 2013
    Report Date
    July 15, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, OUR AFFILIATE IN (B)(6) WAS NOTIFIED BY AN EYE CARE PROVIDER WHO REPORTED A CORNEAL ABSCESS TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION RECEIVED STATES THE ABSCESS WAS OS AND 1MM IN DIAMETER. TREATMENT WAS WITH VICANOX Q2H. NO OTHER INFORMATION IS AVAILABLE. ELEVEN SEALED BLISTERS WERE RETURNED. THE PARAMETERS WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. ONE EDGE CHIP WAS OBSERVED. THE SOLUTION WAS ALSO TESTED. THE PH AND CONDUCTIVITY WERE WITHIN SPECIFICATION. A DEVICE HISTORY REVIEW WAS PERFORMED: 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. NO QUALITY EVENTS ASSOCIATED WITH THIS LOT. THE LOT HISTORY REVIEW INDICATED LOT B00FBKS WAS MANUFACTURED UNDER NORMAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327795 ACUVUE ADVANCE PLUS BRAND CONTACT LENSES SOFT CONTACT LENS (DISPOSABLE) LPL VISTAKON NA B00FBKS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R