BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 6946270 · Received October 12, 2017

    Report

    Report Number
    3008401069-2017-00010
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 15, 2017
    Report Date
    October 12, 2017
    Manufacturer
    ACUFOCUS, INC.
    Product Code
    LQE
    UDI-DI
    00813359020052
    PMA / PMN Number
    P120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM A FEMALE PATIENT DUE TO AN INFILTRATE ADJACENT TO THE INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725349 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A599-0116 00813359020052

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention