BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE MOIST

    MDR report key: 1830934 · Received September 7, 2010

    Report

    Report Number
    1033553-2010-00055
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    June 27, 2010
    Report Date
    September 7, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    (B)(6), REPORTED CORNEAL ULCER OR ABSCESS OS. (B)(4). REPORTED AS 1.5 CM BUT MORE LIKELY TO BE 1.5 MM. REPORTED ANTERIOR CHAMBER INFLAMMATION. REPORT STATES ORGANISM IDENTIFIED AS PSEUDOMONAS AERUGINOSA. THE PT WAS DIAGNOSED 24 HOURS AFTER ONSET OF PAIN. THE REPORT STATES THE PT WAS CONSIDERED TO BE COMPLIANT. PRODUCT IS NOT AVAILABLE FOR EVAL AND NO LOT INFO WAS PROVIDED. IF ADD'L INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MGMT REVIEW MEETINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention