BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY TORIC (SOMOFILCON A)

    MDR report key: 16976707 · Received May 22, 2023

    Report

    Report Number
    3009108089-2023-00003
    Event Type
    Injury
    Date Received
    May 22, 2023
    Report Date
    May 22, 2023
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN MADE AVAILABLE FOR MANUFACTURER ANALYSIS. LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE INCIDENT. 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.

    Description of Event or Problem · 0

    THIS INCIDENT WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL AS REPORTED BY THE USER AND LIMITED INFORMATION IS KNOWN. THE PATIENT STATED THAT THEY BELIEVED THEY REMOVED THEIR CONTACT LENSES, BUT AFTER A FEW DAYS, DEVELOPED IRRITATION THE LEFT EYE. UPON VISITING A&E (ACCIDENT AND EMERGENCY) OPHTHALMOLOGY DEPARTMENT, THEY FOUND A LENS IN HIS EYE AND DIAGNOSE HIM WITH AN EYE INFECTION. THE INFECTION HAS SINCE BEEN TREATED SUCCESSFULLY, LEAVING NO PERMANENT HARM. PATIENT ALLEGES HE HAD RECEIVED A CASE WITH TWO LENSES WHERE HE UNKNOWINGLY INSERTED TWO LENSES INTO HIS EYE AND ONLY REMOVED ONE, RESULTING IN THE REMAINING LENS CAUSING THE IRRITATION AND INFECTION. HIS EYE CARE PRACTITIONER, OPTOM DIR AT SPECSAVERS, DOES NOT BELIEVE THIS TO BE THE CASE AS THE PATIENT DID NOT INDICATE ANY POOR VISION OR OTHER DISCOMFORT WHILE WEARING THAT WOULD INDICATE HAVING INSTILLED TWO LENSES. AS OF THE DATE OF THIS REPORT ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION DUE TO THE UNKNOWN NATURE OR SEVERITY OF THE INCIDENT. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647580 CLARITI 1 DAY TORIC (SOMOFILCON A) CLARITI 1 DAY TORIC (SOMOFILCON A) MVN COOPERVISION CL KFT T0127676

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other