BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)

    MDR report key: 8947083 · Received August 29, 2019

    Report

    Report Number
    2640128-2019-00006
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    June 20, 2019
    Report Date
    September 19, 2019
    Manufacturer
    COOPERVISION CARRIBEAN CORPORATION
    Product Code
    MVN
    PMA / PMN Number
    K020389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INCORRECT MANUFACTURER PMA/510(K) NUMBER USED. INITIALLY REPORTED AS K113267, SHOULD BE K020389.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR DEVICE EVALUATION, HOWEVER, A LOT NUMBER WAS PROVIDED FOR INVESTIGATION. LOT HISTORY, DEVICE HISTORY, STERILIZATION RECORDS AND TREND REPORTING WERE REVIEWED. NO ISSUES OR NONCONFORMANCE'S WERE FOUND AND NO TRENDS WERE IDENTIFIED, NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE EVENT IS UNCONFIRMED. [MW5088388].

    Description of Event or Problem · 1

    INFORMATION RECEIVED VIA MEDWATCH VOLUNTARY USER REPORT MW5088388. THE PATIENT REPORTED THAT SHE EXPERIENCED AN ALLERGIC TYPE RESPONSE IN THE EYES AFTER USING THE DEVICE WITH SYMPTOMS OF BURNING, SWELLING, EYE PAIN. THE PATIENT STATES THAT SHE SOUGHT EMERGENCY MEDICAL TREATMENT, AS WELL AS SEVERAL FOLLOW-UP VISITS WITH HER EYE CARE PROVIDER OVER A ONE-MONTH PERIOD AND WAS PRESCRIBED PREDNISONE EYE DROPS TO BE USED FOR TWO WEEKS. THE PATIENT HAS INDICATED THAT HER EYES HAVE HEALED. GOOD FAITH EFFORTS WERE MADE BY THE MANUFACTURER TO CONTACT THE USER AND REQUEST ADDITIONAL DETAILS. NO RESPONSE HAS BEEN RECEIVED FROM THE USER, ADDITIONAL INFORMATION REGARDING THE EVENT IS UNKNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO INCOMPLETE DIAGNOSIS AND LACK OF MEDICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741151 BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B) BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B) MVN COOPERVISION CARRIBEAN CORPORATION 11198505070015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other