BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT 1 DAY (SOMOFILCON A)

    MDR report key: 11631574 · Received April 7, 2021

    Report

    Report Number
    3009108089-2021-00002
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    February 28, 2021
    Report Date
    April 7, 2021
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO ISSUES OR NON-CONFORMANCES WERE FOUND DURING INVESTIGATION, NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    INCIDENT REPORT RECEIVED FROM (B)(6) MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (B)(6). THE PATIENT REPORTS THAT AFTER TWO DAYS OF USE WITH THE DEVICE THE PATIENT EXPERIENCED A CORNEAL ULCER. AS OF THE DATE OF THE REPORT WITH (B)(6) THE PATIENT WAS STILL UNDERGOING TREATMENT. THE PATIENT PROVIDED THE CONTACT INFORMATION FOR THE LOCATION OF PURCHASE, (B)(6). THE MANUFACTURER CONTACTED THE PURCHASE LOCATION FOR ADDITIONAL INFORMATION ON THE EVENT. (B)(6)REPORTS THE PATIENT CONTACTED THEM VIA PHONE CALL TO REPORT THAT SHE WAS SEEN IN THE HOSPITAL AND BY AN EYE SPECIALIST FOR A MEDICAL EVENT AFTER USING HER CONTACT LENSES. AS THE PATIENT WAS NOT TREATED AT THE (B)(6) LOCATION ADDITIONAL DETAILS REGARDING THE EVENT COULD NOT BE PROVIDED, ONLY THE DETAILS THE PATIENT PROVIDED VIA PHONE CALL. THE PATIENT DID NOT PROVIDE THE CONTACT INFORMATION FOR THE HOSPITAL LOCATION OR EYE SPECIALIST WHO TREATED HER FOR THE INCIDENT. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION WITHOUT SUCCESS, ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO UNCONFIRMED DIAGNOSIS, LACK OF MEDICAL INFORMATION, AND UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526593 SELECT 1 DAY (SOMOFILCON A) SELECT 1 DAY (SOMOFILCON A) MVN COOPERVISION CL KFT V0043247

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other