BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 CONTACT LENSES

    MDR report key: 1084351 · Received July 30, 2008

    Report

    Report Number
    1033553-2008-00084
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    May 5, 2008
    Report Date
    July 30, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    MEMBERS OF OUR AFFILIATE ATTENDED THE 45TH ANTHER COUNTRY'S ASSOCIATION FOR OCULAR INFECTION. THE FOLLOWING CASE WAS PRESENTED. A PT WEARING ACUVUE 2 LENSES DEVELOPED ACANTHAMOEBA KERATITIS. THE FOLLOWING INFO WAS PROVIDED AT THE CONFERENCE AND THROUGH A MONITORING FORM SENT TO THE PRESENTING DOCTOR. THE PT WAS SEEN IN 2007 WITH PAIN OD. THE PT WAS REFERRED TO A HOSPITAL ON THE FOLLOWING MONTH, WHERE RADIAL KERATONEURITIS AND MULTIPLE MICROINVASIONS IN TEMPORAL EPITHELIUM AND SUPERFICIAL STROMA WERE OBSERVED. TREATMENT: EYE DROPS (MICONAZOLE, CHLORHEXIDINE GLUCONATE, VORICONAZOLE) AND ADMINISTERED OCULAR OINTMENT: (PIMARICIN). OUTCOME: VA 0.6 (20/35) 10 DAYS AFTER STARTING TREATMENT. VA IMPROVED TO 1.0 (20/20) ON THE 17TH DAY AFTER BEGINNING TREATMENT. ON ELEVEN DAYS LATER THE PT WAS DISCHARGED FROM THE HOSPITAL. LENS CARE: THE PT REPLACED MULTIPURPOSE SOLUTION EVERY DAY. -ROHTO C3 SOFT ONE MOIST (ROHTO PHARMACEUTICAL CO., LTD.) AND RUBBED CLS OCCASIONALLY. THE PT ALLOWED THE LENS CASE TO AIR DRY. THE PT REPORTEDLY ALSO RUBBED LENSES WITH WATER. WEARING SCHEDULE: 16 HOURS PER DAY. NO ADD'L INFO PROVIDED. MDR'S ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention