BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE

    MDR report key: 1790073 · Received August 6, 2010

    Report

    Report Number
    1033553-2010-00049
    Event Type
    Injury
    Date Received
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    (B)(4) AFFILIATE REPORTED A PT HOSPITALIZED FOR TREATMENT OF A MICROBIAL KERATITIS. THE ONSET WAS APPROXIMATELY ONE MONTH AGO. REPORTEDLY, VISUAL ACUITY WAS NOT AFFECTED DUE TO THE SMALL SIZE OF THE INFILTRATE AND LOCATION OUTSIDE OF THE VISUAL AXIS. THE PT WAS WEARING 1-DAY ACUVUE TRUEYE. LITTLE INFO IS AVAILABLE AT THIS TIME. TREATMENT RECORDS HAVE BEEN REQUESTED WHEN PT'S TREATMENT IS COMPLETE. THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY DUE TO THE HOSPITAL TREATMENT AND DIAGNOSIS OF MICROBIAL KERATITIS. IF ADDITIONAL INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization LENS CARE SOLUTION UNK