BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5204297 · Received November 5, 2015

    Report

    Report Number
    3008401069-2015-00006
    Event Type
    Injury
    Date Received
    November 5, 2015
    Date of Event
    July 31, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW A REVIEW OF THE DEVICE HISTORY RECORD (DHR), A530-0214, 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 0.2 EU/DEVICE 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. OCT. 16, 2015. A VISUAL ANALYSIS OF THE RETURNED INLAY FOUND THE INLAY WAS FOLDED AND FRAYED WHERE ACCURATE MEASUREMENTS COULD NOT BE TAKEN. 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. LOT HISTORY A530-0214 A REVIEW OF THE COMPLAINT HISTORY FOR PRODUCTION LOT (BATCH) A530-0214 WAS PERFORMED. A TOTAL OF TWO (2) OTHER COMPLAINTS WERE RECEIVED FOR THIS LOT. ONE OF THE COMPLAINTS IS CLASSIFIED AS NON MEDICAL AND WILL NOT BE REPORTED AS AN ADVERSE EVENT. THE OTHER COMPLAINT WAS DUE TO INFLAMMATION AND WILL BE REPORTED AS AN ADVERSE EVENT. PRELIMINARY ASSESSMENT BASED ON THE REPORTED INFORMATION AND PRELIMINARY ANALYSIS INCLUDING NO NOTED DISCREPANCIES IN THE DHR THAT RELATE TO THE EVENT, THERE IS NO EVIDENCE TO SUGGEST THE EVENT IS SYSTEMIC AND/OR DEVICE RELATED. THEREFORE, BASED ON THE INFORMATION KNOWN TO DATE, THE MOST LIKELY CONTRIBUTOR TO THE SUSPECTED INFECTION WAS LIKELY THE PATIENT'S NON-COMPLIANCE TO POSTOPERATIVE EYE DROP REGIMEN WHICH RESULTED IN THE IRRITATED EYES AND NOTED INFILTRATES WITHIN THE FIRST TWO WEEKS OF THE PROCEDURE. LABELING REVIEW BASED ON THE REPORTED INFORMATION, THE PROCEDURE TYPE PERFORMED WAS A . 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." SURGEON TRAINING ACUFOCU'S SURGEON TRAINING INCLUDES THE PLK2 (PLANNED LASIK KAMRA 2 STEP) WHICH DESCRIBES PERFORMING A STANDARD FLAP CREATION WITH EXCIMER ABLATION TREATMENT (LASIK) FOLLOWED BY POCKET CREATION AND KAMRA INLAY IMPLANTATION AT A MINIMUM OF ONE (1) MONTH POST LASIK TREATMENT. THE PROCEDURES PERFORMED IN THIS EVENT WERE PERFORMED CONSECUTIVELY ON THE SAME DAY, AND THEREFORE ARE NOT CONSISTENT WITH ACUFOCUS' RECOMMENDATIONS. ACUFOCUS HAS NOT REACHED A CONCLUSION INTO THE ROOT CAUSE OF INFECTION/INFLAMMATION EVENTS FROM OPTILASE EYE CLINICS. 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 OPTILASE EYE CLINICS IN THE REPUBLIC OF IRELAND AND NORTHERN IRELAND 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

    PATIENT CODES WAS UPDATED FROM KERATITIS TO INFLAMMATION AND INFILTRATE BASED ON THE RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6), 2015, ACUFOCUS BECAME AWARE THAT THE KAMRA CORNEAL INLAY WAS EXPLANTED EIGHT (8) DAYS POSTOPERATIVELY FROM THE LEFT EYE, DUE TO A SUSPECTED INFECTION. THE PATIENT UNDERWENT A SAME DAY LASIK AND KAMRA IMPLANTATION IN A SECONDARY LAMELLAR POCKET ON (B)(6), 2015. THE INFORMATION PROVIDED BY THE CLINIC NOTED THAT THE PATIENT ADMITTED TO NOT USING POSTOPERATIVE EYE DROP REGIMEN AS OFTEN AS INSTRUCTED. UNCORRECTED VISUAL ACUITY (UCVA) READINGS WHILE THE INLAY WAS IMPLANTED WAS NOTED AS 20/16 ON THE FIRST DAY POSTOPERATIVELY AND 20/20 ON THE EIGHTH DAY WHEN THE INLAY WAS EXPLANTED. ON (B)(6), 2015, DURING THE INLAY REMOVAL, SCRAPING WAS DONE, THE FLAP WAS LIFTED, AND A SAMPLE WAS COLLECTED AND SENT TO THE LAB FOR ANALYSIS. THE PATIENT WAS PRESCRIBED OFTAQUIX HOURLY AND CHLORAMPHENICOL OINTMENT QDS (4 TIMES/DAY) AND AT NIGHT. THE PATIENT WAS REFERRED TO ANOTHER OPHTHALMOLOGIST FOR KERATITIS MANAGEMENT. ON (B)(6), 2015, LAB RESULTS FOUND THERE WAS NO MICROORGANISMS IN THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736150 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A530-0214

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention