BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5248591 · Received November 24, 2015

    Report

    Report Number
    3008401069-2015-00012
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    March 9, 2013
    Report Date
    April 22, 2016
    Manufacturer
    ACUFOCUS, INC.
    Product Code
    LQE
    PMA / PMN Number
    P120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT CODES WERE UPDATED TO INFILTRATE AND INFLAMMATION BASED ON THE RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2015, ACUFOCUS, INC. BECAME AWARE OF AN INLAY BEING EXPLANTED ONE (1) MONTH AND TWO (2) DAYS POSTOPERATIVELY FROM THE RIGHT EYE OF A (B)(6) YEAR OLD FEMALE PATIENT DUE TO A SEVERE INFLAMMATORY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778512 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A372-0612

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention