BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5269125 · Received December 4, 2015

    Report

    Report Number
    3008401069-2015-00016
    Event Type
    Injury
    Date Received
    December 4, 2015
    Date of Event
    August 25, 2015
    Report Date
    July 15, 2016
    Manufacturer
    ACUFOCUS, INC.
    Product Code
    LQE
    PMA / PMN Number
    P120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, ACUFOCUS, INC. BECAME AWARE OF NEW INFORMATION WHICH REPORTED THAT THE INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) MALE PATIENT 2 YEARS, 11 MONTHS, AND 7 DAYS POSTOPERATIVELY DUE TO AN EPITHELIAL DEFECT/INGROWTH/EROSION AND CORNEAL HAZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798140 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A343-0412

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention