BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 6152350 · Received December 7, 2016

    Report

    Report Number
    3008401069-2016-00021
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 7, 2016
    Report Date
    February 1, 2017
    Manufacturer
    ACUFOCUS, INC.
    Product Code
    LQE
    UDI-DI
    00813359020007
    PMA / PMN Number
    P120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT TO RETRIEVE THE LOT NUMBER FROM THE REPORTER WAS PERFORMED. HOWEVER, THE REPORTER STATED THAT THEY DID NOT RECORD THE LOT NUMBER; THEREFORE THE LOT NUMBER ASSOCIATED WITH THIS EVENT CANNOT BE RETRIEVED.

    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 BLURRED VISION.

    Description of Event or Problem · 1

    UPDATED INFORMATION: PATIENT WAS LAST SEEN ON (B)(6) 2016. AT THIS TIME HER UCDVA WAS REPORTED TO BE 20/70 WITH A 1+ HAZE IN THE POCKET AND 2+ SPK. THE PATIENT WILL DISCONTINUE PREDNISOLONE AND RETURN TO THE CLINIC IN ONE (1) MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803941 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 00813359020007

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention