BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5125625 · Received October 2, 2015

    Report

    Report Number
    3008401069-2015-00001
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    May 28, 2015
    Report Date
    April 22, 2016
    Manufacturer
    ACUFOCUS, INC.
    Product Code
    LQE
    PMA / PMN Number
    P120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE APOLOGIZE FOR THE TIMELINESS OF THIS REPORT; CAPA (B)(4) HAS BEEN INITIATED TO INVESTIGATE AND CORRECT THIS ISSUE. DEVICE EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THERE WERE NO DISCREPANCIES NOTED THAT RELATE TO THE EVENT. THE DEVICE WAS RETURNED TO ACUFOCUS, INC. ON (B)(4) 2015. A VISUAL ANALYSIS FOUND THE INLAY WAS FOLDED ON ONE SIDE WHERE ACCURATE MEASUREMENTS COULD ONLY BE TAKEN ON ONE SIDE OF THE DEVICE. THE MEASUREMENTS TAKEN WERE FOUND TO BE WITHIN SPECIFICATION. THE NOTED DAMAGE IS CONSISTENT WITH THAT OF AN EXPLANTED INLAY AND DUE TO DAMAGE DURING HANDLING FROM THE EXPLANT PROCEDURE. HENCE, WE CANNOT ATTRIBUTE THE RECEIPT CONDITION OF THE INLAY TO THE DEVICE. ACUFOCUS, INC. DOES NOT BELIEVE THE ALLEGED EVENT TO BE MANUFACTURING PROCESS AND/OR DEVICE RELATED. THE COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND ACTION TAKEN IF DEEMED REQUIRED. ALL (B)(4) UNITS PRODUCED AS LOT A529-0214 HAVE BEEN DISTRIBUTED AND NO OTHER COMPLAINTS OF INFLAMMATION WERE REPORTED FOR THIS LOT. THEREFORE, THE ALLEGED EVENT IS NOT BELIEVED TO BE LOT RELATED. ACUFOCUS ANTICIPATES RECEIVING AN UPDATE FROM THE DISTRIBUTOR REGARDING THE PATIENT'S PROGRESS AT THE END OF (B)(4) 2015. ANY NEW INFORMATION WILL BE PROVIDED TO THE FDA ON A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON JULY 22, 2015, ACUFOCUS INC. BECAME AWARE THAT THE KAMRA CORNEAL INLAY WAS EXPLANTED FIVE (5) DAYS POSTOPERATIVELY DUE TO AN INFLAMMATORY REACTION.

    Description of Event or Problem · 1

    ON (B)(4) 2015, ACUFOCUS, INC. BECAME AWARE THAT THE KAMRA CORNEAL INLAY WAS EXPLANTED FIVE (5) DAYS POSTOPERATIVELY DUE TO AN INFLAMMATORY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652442 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A529-0214

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention