BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5717244 · Received June 10, 2016

    Report

    Report Number
    3008401069-2016-00009
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 11, 2016
    Report Date
    February 10, 2017
    Manufacturer
    ACUFOCUS, INC.
    Product Code
    LQE
    UDI-DI
    00813359020007
    PMA / PMN Number
    P120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT AND THERAPY DATES WAS CONFIRMED TO BE ASA AND THE DATE WAS CORRECTED TO (B)(6) 2015. THE LASER USED IN THE POCKET CREATION WAS ADDED TO THE LIST. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATE: INFORMATION WAS UPDATED.

    Description of Event or Problem · 1

    THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) FEMALE PATIENT APPROXIMATELY FIVE (5) MONTHS POSTOPERATIVELY DUE TO CORNEAL HAZE AND BLURRED VISION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINIC ON (B)(6) 2016 THAT THE PATIENT'S VISION HAS NOT IMPROVED MUCH AND IS STILL AT 20/100.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S VISION HAS IMPROVED TO 20/40 AS OF THE FIRST WEEK OF (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372155 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A556-0515 00813359020007

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention