BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY MULTIFOCAL (COMFILCON A)

    MDR report key: 20951592 · Received December 17, 2024

    Report

    Report Number
    9614392-2024-00062
    Event Type
    Injury
    Date Received
    December 17, 2024
    Report Date
    December 17, 2024
    Manufacturer
    COOPERVISION MANUFACTURING, LTD
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE SAMPLE RETURNED FOR MANUFACTURER ANALYSIS AND NO LOT NUMBER REPORTED, NO INVESTIGATION COULD BE COMPLETED. GIVEN THE LACK OF AVAILABLE EVENT AND DEVICE DETAILS, NO ROOT CAUSE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY THE DISTRIBUTOR AS RELAYED BY THE PATIENT. IT WAS REPORTED THAT THE PATIENT PURCHASED CONTACT LENS IN (B)(6) 2024, AND AFTER APPROXIMATELY SEVEN DAYS OF USE EXPERIENCED EYE PAIN AND DISCONTINUED LENS USE. THE EYE PAIN DID NOT SUBSIDE, AND THE PATIENT FELT UNWELL AND SOUGHT MEDICAL ATTENTION AT AN EYE CLINIC. THE PATIENT ALLEGED THEY WERE TOLD THAT THE EVENT WAS CAUSED BY THE CONTACT LENSES BUT COULD NOT BE TREATED AT THIS FACILITY AND WERE REFERRED TO A (B)(6). THE PATIENT STATES THEY WERE INFORMED BY THE (B)(6) THERE WAS AN INFECTION AND ABRASIONS PRESENT, HOWEVER TREATMENT COULD NOT BEGIN UNTIL THE SEVERE REDNESS SUBSIDED. THE PATIENT INDICATES THEY EXPERIENCED DECREASED VISION AND MAY REQUIRE SURGERY. FURTHER INFORMATION WAS RECEIVED STATING THAT ON (B)(6) 2024 THE PATIENT WAS SEEN AT THE (B)(6) FOR FOLLOW-UP AND THAT THE INFECTION WAS STILL PRESENT. SURGERY WOULD NOT TAKE PLACE UNTIL AFTER THE INFECTION HAS RESOLVED. AT THE TIME OF THE REPORT THE PATIENT INDICATES CONTINUED REDUCED VISION AND THAT THEY ARE CURRENTLY USING AN EYE PATCH. THE PATIENT WAS SEEN FOR ANOTHER FOLLOW-UP VISIT (B)(6) 2024 AND REPORTS THAT THE INFLAMMATION HAS SUBSIDED BUT NOT RESOLVED AND THEY CONTINUE TO EXPERIENCE REDUCED VISION. TREATMENT WILL CONTINUE UNTIL THE INFLAMMATION HAS RESOLVED AT WHICH TIME THE PATIENT WILL BE ASSESSED FOR SURGERY. AS OF THE DATE OF THIS REPORT NO FURTHER INFORMATION HAS BEEN RECEIVED ON THE PATIENT'S CURRENT CONDITION. THIS EVENT IS BEING REPORTED DUE TO THE ALLEGATION OF INFECTION REQUIRING MEDICAL AND/OR SURGICAL INTERVENTION TO PREVENT OR PRECLUDE PERMANENT INJURY AND THE POTENTIAL FOR PERMANENT INJURY (PATIENT OUTCOME UNKNOWN). SHOULD FURTHER INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL COMPLETE FURTHER INVESTIGATIONS AS APPROPRIATE AND SUBMIT A FOLLOW-UP REPORT AS APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486157 BIOFINITY MULTIFOCAL (COMFILCON A) BIOFINITY MULTIFOCAL (COMFILCON A) LPM COOPERVISION MANUFACTURING, LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other