BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY MULTIFOCAL (COMFILCON A)

    MDR report key: 8184478 · Received December 20, 2018

    Report

    Report Number
    9614392-2018-00048
    Event Type
    Injury
    Date Received
    December 20, 2018
    Report Date
    December 20, 2018
    Manufacturer
    COOPERVISION MANUFACTURING LTD
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO LENSES WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. 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 EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE PATIENT ALLEGES THAT THEY EXPERIENCED SEVERE PERSONAL INJURIES INCLUDING PAIN AND IMPAIRED VISION, AND MEDICAL COMPLICATIONS INCLUDING SURGICAL PROCEDURES AND PERMANENT INJURY FROM THE USED OF THE DEVICE. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS; ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO INCOMPLETE DIAGNOSIS, LACK OF MEDICAL INFORMATION, AND UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024224 BIOFINITY MULTIFOCAL (COMFILCON A) BIOFINITY MULTIFOCAL (COMFILCON A) LPM COOPERVISION MANUFACTURING LTD 10611000013501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S