BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5248772 · Received November 24, 2015

    Report

    Report Number
    3008401069-2015-00015
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    October 10, 2014
    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

    (B)(4). DEVICE NOT RETURNED TO ACUFOCUS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2015, ACUFOCUS, INC. BECAME AWARE THAT A KAMRA INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) FEMALE PATIENT, 15 DAYS POSTOPERATIVELY ((B)(6), 2014) IN ORDER TO AID THE HEALING PROCESS OF THE PATIENT'S SUSPECTED KERATITIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778507 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A515-1213

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention