BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5202885 · Received November 4, 2015

    Report

    Report Number
    3008401069-2015-00005
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    May 19, 2015
    Report Date
    November 4, 2015
    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

    WE APOLOGIZE FOR THE TIMELINESS OF THIS REPORT; (B)(4) HAS BEEN INITIATED TO INVESTIGATE AND CORRECT THIS ISSUE. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND THERE WERE NO DISCREPANCIES NOTED THAT RELATE TO THE EVENT. PRODUCTION PROCESS CONTROL REVIEW: A REVIEW OF THE PROCESS CONTROL RECORDS REGARDING THE STERILIZATION OF THE DEVICE CONFIRMED THE STERILIZATION CYCLE FOR THIS LOT (BATCH) MET THE REQUIRED SPECIFICATIONS, INCLUDING RESULTS OF THE BIOLOGICAL INDICATORS.  THE ENDOTOXIN TESTING FOR THIS LOT VIA LAL TESTING FOUND THE BATCH CONTAINED LESS THAN (B)(4) AND WAS ACCEPTABLE FOR RELEASE.  ADDITIONALLY, ACUFOCUS TAKES QUARTERLY BIOBURDEN SAMPLES TO ENSURE THE CONSISTENCY OF THE PRODUCTION PROCESS AND NO CHANGES HAVE OCCURRED TO THE PRODUCT WHICH HAVE AFFECTED THE EFFICACY OF THE STERILIZATION CYCLE. RETURNED DEVICE ANALYSIS: THE DEVICE WAS RETURNED TO ACUFOCUS, INC. ON JULY 28, 2015. A VISUAL ANALYSIS FOUND THE INLAY WAS WRINKLED AND WARPED; CONSISTENT WITH BEING EXPLANTED. DESPITE THE NOTED DAMAGE, THE INNER DIAMETER AND OUTER DIAMETER MEASUREMENTS OF THE INLAY 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. LOT HISTORY: A REVIEW OF THE COMPLAINT HISTORY FOR THE PRODUCTION LOT (BATCH) A526-0114 WAS PERFORMED. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT (BATCH). LABELING REVIEW: BASED ON THE REPORTED INFORMATION, THE PROCEDURE TYPE PERFORMED WAS SAME DAY LASIK AND KAMRA IMPLANTATION IN SECONDARY LAMELLAR POCKET. 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."

    Description of Event or Problem · 1

    ON (B)(6) 2015 ACUFOCUS BECAME AWARE OF A KAMRA INLAY BEING EXPLANTED APPROXIMATELY 17 DAYS POSTOPERATIVELY DUE TO THE CORNEAL FLAP NOT HEALING. ON (B)(6) 2015 ACUFOCUS, INC., RECEIVED ADDITIONAL INFORMATION WHICH STATED THE REASON FOR THE EXPLANT WAS DUE TO AN EPITHELIAL INGROWTH. THE EVENT WAS RE-ASSESSED BASED ON THE NEW INFORMATION AND FOUND TO BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731070 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. 76195 A526-0114

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention