BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5203149 · Received November 4, 2015

    Report

    Report Number
    3008401069-2015-00008
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    July 29, 2015
    Report Date
    June 13, 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

    Additional Manufacturer Narrative · 1

    A DHR (DEVICE HISTORY RECORD) REVIEW AND LOT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. RETURNED DEVICE ANALYSIS VISUAL ANALYSIS FOUND THE INLAY WRINKLED AND WARPED. 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 TO THE DEVICE. BASED ON THE REPORTED INFORMATION, THE PROCEDURE TYPE PERFORMED WAS A UNILATERAL PRK (PHOTOREFRACTIVE KERATECTOMY) WITH A KAMRA POCKET PROCEDURE. THE UNITED STATES LABELING (P/N 61017, REV. J) FOR THE KAMRA INLAY CONTAINS THE FOLLOWING PRECAUTION: "THE SAFETY AND EFFECTIVENESS OF THE KAMRA INLAY IMPLANTATION IN CONJUNCTION WITH OR IN SEQUENCE WITH LASIK OR OTHER REFRACTIVE PROCEDURES IN NOT KNOWN." ACUFOCUS HAS NOT REACHED A CONCLUSION INTO THE ROOT CAUSE OF INFECTION/INFLAMMATION EVENTS FROM (B)(6). HOWEVER, BASED ON INFORMATION KNOWN TO DATE, THERE IS INSUFFICIENT EVIDENCE TO SUGGEST THE REPORTED EVENTS ARE SYSTEMIC AND/OR DEVICE RELATED BASED ON ACCEPTABLE ACUFOCUS DHR/STERILITY REVIEW, COMPLAINT TRENDING ON AFFECTED LOTS AND PRODUCT EVALUATIONS. ACUFOCUS HAS INITIATED A MORE THOROUGH ASSESSMENT OF THE CLINIC'S PRACTICES IN ATTEMPT TO IDENTIFY A ROOT CAUSE FOR THE REPORTED EVENTS AND HAS ESTABLISHED CAPA (B)(4) IN THE ACUFOCUS QUALITY MANAGEMENT SYSTEM. AS PART OF THE INVESTIGATION PLAN, ACUFOCUS VISITED THE (B)(6) IN LATE OCTOBER TO CONDUCT A REVIEW THE PATIENT FILES ASSOCIATED WITH THE REPORTED EVENTS, ASSESS THE SURGICAL PRACTICES AND PROCEDURES USED FOR KAMRA IMPLANTATION, SURGICAL SUITES/ENVIRONMENTAL CONTROLS, TOOLS AND EQUIPMENT, PREOPERATIVE AND POSTOPERATIVE MEDICATION REGIMEN AND IS IN THE PROCESS OF SUMMARIZING THE VISIT FINDINGS. THE INVESTIGATION IS IN-PROGRESS AND FINDINGS WILL BE RECORDED ON CAPA (B)(4). A SUMMARY OF OUR FINDINGS WILL BE PROVIDED TO THE NCA UPON COMPLETION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON JUL-29-2015, IT WAS REPORTED TO ACUFOCUS, INC. THAT THE PATIENT DEVELOPED A HYPEROPIC SHIFT, POOR NEAR VISION, AND INFLAMMATION SIX (6) MONTHS POSTOPERATIVELY WHICH RESULTED IN THE INLAY BEING EXPLANTED 10 MONTHS AND 26 DAYS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732826 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A509-1013

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention