BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENFILCON A/SUS ONE DAY

    MDR report key: 5048357 · Received September 1, 2015

    Report

    Report Number
    2640128-2015-00011
    Event Type
    Injury
    Date Received
    September 1, 2015
    Report Date
    August 27, 2015
    Manufacturer
    COOPERVISION MANUFACTURING PUERTO RICO, LLC
    Product Code
    MVN
    PMA / PMN Number
    K131378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTACT LENS WAS NOT RETURNED FOR INSPECTION. THE COMPLAINT IS UNCONFIRMED. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE INCIDENT IS UNCONFIRMED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE THAT MEDICAL PERSONNEL CAUSED OR CONTRIBUTED TO THE EVENT AND/OR THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT.

    Additional Manufacturer Narrative · 1

    AN ALLERGIST REVIEWED THE DETAILS OF THE COMPLAINT AND IT'S THEIR EXPERT OPINION THAT THE INCIDENT MIGHT BE ASSOCIATED WITH A LATEX ALLERGY. THERE IS NO LATEX IN THE LENS PRODUCT OR USED IN THE PRODUCTION ENVIRONMENT, THUS, THE LENS COULD NOT HAVE RESULTED IN A LATEX ALLERGY. IT WAS LEARNED THAT FLUORESCEIN WAS USED BY THE PT PRIOR TO INSERTING THE LENSES INTO THE EYES. THERE ARE SEVERAL CASE REPORTS THAT INDICATE THAT FLUORESCEIN CAUSED ANAPHYLAXIS. HENCE, THE POSSIBILITY CANNOT BE DENIED THAT THIS INCIDENT RESULTED FROM FLUORESCEIN USED BEFORE INSERTING THE LENSES. THE COMPLAINT IS UNCONFIRMED. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE INCIDENT IS UNCONFIRMED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE THAT MEDICAL PERSONNEL CAUSED OR CONTRIBUTED TO THE EVENT AND/OR THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE OPTICIAN RELATES THAT AFTER THE LENSES WERE INSERTED INTO THE PATIENT'S EYES, THE OPTICIAN ALLEGES THAT THE PATIENT HAD SYMPTOMS OF ANAPHYLACTIC SHOCK. THE OPTICIAN STATES THAT THE PATIENT WENT TO THE GP AND THEN THE HOSPITAL. THE OPTICIAN DOES NOT HAVE THE LOT NUMBERS FOR THE PRODUCT WHICH SHE USED. EFFORT HAS BEEN MADE TO OBTAIN MEDICAL INFORMATION-NO INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    SUPPLEMENT TO ALIGN REPORT WITH PMDA SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580134 STENFILCON A/SUS ONE DAY STENFILCON A/SUS ONE DAY MVN COOPERVISION MANUFACTURING PUERTO RICO, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other