BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 6049016 · Received October 21, 2016

    Report

    Report Number
    3008401069-2016-00019
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 21, 2016
    Report Date
    April 12, 2017
    Manufacturer
    ACUFOCUS, INC.
    Product Code
    LQE
    UDI-DI
    00813359020007
    PMA / PMN Number
    P120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS ADDED TO THE FOLLOWING OTHER RELEVANT HISTORY, DESCRIBE EVENT OR PROBLEM, AND CONCOMITANT MEDICAL PRODUCTS. ALSO, (B)(4) WERE ADDED. THE INITIAL REPORTED WAS CORRECTED.

    Description of Event or Problem · 1

    THE INLAY WAS EXPLANTED 26 DAYS POSTOPERATIVELY FROM THE LEFT EYE OF A (B)(6) FEMALE DUE TO REPORTED INFECTION AND REJECTION. PATIENT WAS PRESCRIBED THE FOLLOWING MEDICATIONS TO TREAT THE REPORTED CONDITION: OFLOXACIN, PREDFORTE, LOTEMAX, ARTIFICIAL TEARS, ORAL ACYCLOVIR, BACITRACIN OINTMENT, AND ZIRGAN. THE IMPLANTING CLINIC REPORTED THE NECROTIC CORNEAL TISSUE IN THE LEFT EYE WAS DEBULKED AND AN AMBIODISK WAS PLACED IN THE LEFT EYE. PATIENT'S HUSBAND REPORTED ON 11/10/2016 THAT THE PATIENT HAS A CORNEAL ULCER AND VISION LOSS ASSOCIATED WITH A POSTOPERATIVE INFECTION. THE PATIENT HAS SINCE CHANGED PHYSICIANS. FOR A DETAILED SEQUENCE OF EVENTS ASSOCIATED WITH THIS PATIENT, PLEASE REFER TO ATTACHMENT 3. UPDATE: ACUFOCUS RECEIVED AN EMAIL FROM THE PATIENT ON 02/20/2017 STATING THAT SHE HAS "PERMANENT EYE DAMAGE AND WILL NEED A FUTURE CORNEA TRANSPLANT." ACUFOCUS REPLIED TO THE PATIENT ON 2/22/2017, REQUESTING ADDITIONAL INFORMATION. TO DATE, NO FURTHER COMMUNICATION FROM THE PATIENT HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    UPDATED INFORMATION: PATIENT'S HUSBAND REPORTED ON 11/10/2016 THAT THE PATIENT HAS A CORNEAL ULCER AND VISION LOSS ASSOCIATED WITH A POSTOPERATIVE INFECTION. THE PATIENT HAS SINCE CHANGED PHYSICIANS. THE IMPLANTING CLINIC REPORTED THE NECROTIC CORNEAL TISSUE IN THE LEFT EYE WAS DEBULKED AND AN AMBIODISK WAS PLACED IN THE LEFT EYE.

    Description of Event or Problem · 1

    THE INLAY WAS EXPLANTED 26 DAYS POSTOPERATIVELY FROM THE LEFT EYE OF A (B)(6) YEAR OLD FEMALE DUE TO REPORTED INFECTION AND REJECTION. PATIENT IS CURRENTLY TAKING THE FOLLOWING MEDICATIONS TO TREAT THE REPORTED CONDITION: OFLOXACIN, PREDFORTE, LOTEMAX, ARTIFICIAL TEARS, ORAL ACYCLOVIR, BACITRACIN OINTMENT, AND ZIRGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698805 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A575-0715 00813359020007

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention| S LASIK