BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT 1 DAY (OMAFILCON A)

    MDR report key: 15987963 · Received December 15, 2022

    Report

    Report Number
    9614392-2022-00037
    Event Type
    Injury
    Date Received
    December 15, 2022
    Report Date
    December 15, 2022
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    QIT
    PMA / PMN Number
    P180035
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE SAMPLE WAS RETURNED FOR MANUFACTURER ANALYSIS. A LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE INCIDENT. 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 INCIDENT IS UNCONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, COOPERVISION WILL COMPLETE ADDITIONAL INVESTIGATIONS AND SUBMIT A FOLLOW-UP REPORT AS APPROPRIATE. AS THE PATIENT WAS USING A DIFFERENT DEVICE IN EACH EYE AND IT IS UNKNOWN WHICH DEVICE WAS OR MAY HAVE BEEN INVOLVED IN THE INCIDENT, PLEASE REFER TO MANUFACTURER REPORT REFERENCE 9614392-2022-00036 FOR ASSOCIATED INCIDENT/DEVICE REPORT.

    Description of Event or Problem · 0

    THE INCIDENT WAS REPORTED BY THE PRESCRIBING EYE CARE PRACTITIONER, HOWEVER, LIMITED INFORMATION HAS BEEN MADE AVAILABLE. THE PRACTITIONER STATES THEY WILL NOT PROVIDE FURTHER INFORMATION AS THIS IS CONFIDENTIAL MEDICAL RECORDS. IT IS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC TYPE REACTION AFTER USING THE DEVICE AND SUFFERED FROM ANAPHYLACTIC SHOCK. THE PATIENT WILL WORK WITH AN ALLERGOLOGIST TO DETERMINE POTENTIAL ALLERGEN(S) EXPOSED TO THAT CAUSED THE REACTION. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION WITHOUT SUCCESS, AS OF THE DATE OF THIS REPORT ADDITIONAL INFORMATION IS UNKNOWN. SHOULD FURTHER INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO THE SERIOUS NATURE OF THE EVENT, LACK OF MEDICAL INFORMATION, UNCONFIRMED DIAGNOSIS, AND UNKNOWN PATIENT RESOLUTION. NO LENSES RETURNED FOR ANALYSIS, IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITION. AS THE PATIENT WAS USING A DIFFERENT DEVICE IN EACH EYE AND IT IS UNKNOWN WHICH DEVICE WAS OR MAY HAVE BEEN INVOLVED IN THE INCIDENT, PLEASE REFER TO MANUFACTURER REPORT REFERENCE 9614392-2022-00036 FOR ASSOCIATED INCIDENT/DEVICE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996790 MISIGHT 1 DAY (OMAFILCON A) MISIGHT 1 DAY (OMAFILCON A) QIT COOPERVISION MANUFACTURING, LTD. 29634820123006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other