BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 BRAND

    MDR report key: 2161985 · Received July 11, 2011

    Report

    Report Number
    1033553-2011-00044
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 11, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT LENSES HAVE BEEN REQUESTED BUT NOT RECEIVED. LOT #L001JKN WAS REPORTED AS THE SUSPECT LOT NUMBER. 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. OUR AFFILIATE REPORTED THAT "THE CONSUMER HAS FOUR CLOSED UNITS" AND WAS THE SAME RX OU. THE LENSES WERE REQUESTED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. (B)(4). DEVICE LABELING SINGLE USE OR REUSE. DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    (B)(4) AFFILIATE REPORTED PATIENT (PT) WITH A CORNEAL ULCER OU WHILE WEARING ACUVUE 2 CONTACT LENSES (CL). THIS REPORT IS FOR THE EVENT OD; THE OS IS REPORTED IN FILE 1033553-2011-00045. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2011 AND WAS TREATED WITH "VIGADEXA" EYE DROPS. THE SUSPECT LENSES HAVE BEEN REQUESTED IF IT IS AVAILABLE BUT NOT RECEIVED. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL. THE PATIENT WAS CHANGING CL EVERY 30 DAYS, AND USING OPTI-FREE MPS TO CLEAN/DISINFECT THEM. OUR AFFILIATE SPOKE WITH "THE PATIENT'S OPHTHALMOLOGIST ON WEDNESDAY (B)(6), WHEN SHE TOLD ME THE PATIENT WAS GETTING BETTER EACH DAY, AND THAT THE ULCER WAS ALMOST HEALED. THE NATURE OF THE ULCER WAS SUPPOSED TO BE INFECTIOUS, BUT THE OPHTHALMOLOGIST HAS NOT DONE ANY CULTURE OR COLLECTED ANY OTHER COMPLIMENTARY EXAM. THE ULCER WAS NOT IN CENTRAL CORNEA - ALL WERE IN THE PERIPHERY. THE OPHTHALMOLOGIST HAS NOT PROVIDED ANY INFORMATION ON THE PATIENT'S VISUAL ACUITY." THE PATIENT "WAS PRESCRIBED MOXIFLOXACIN EYE DROPS EVERY 3 HOURS FROM THE 2ND DAY ON (STARTED WITH EVERY 15 MINUTES FOR 1 HOURS, THEN EVERY 30 MIN FOR MORE 1 HOUR, THEN EVERY HOUR UNTIL SLEEP IN THE FIRST DAY), NEVANAC QID AND SYSTANE QID."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE 2 BRAND DISPOSABLE SOFT CONTACT LENS LPL VISTAKON NA L001JKN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other OPTI FREE MPS