BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE

    MDR report key: 4971291 · Received August 5, 2015

    Report

    Report Number
    2648035-2015-00575
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    June 2, 2015
    Report Date
    October 23, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE AVAILABLE FOR EVALUATION: THERE WAS A TYPO IN THE INITIAL MDR AND THE QUESTION TO THIS SECTION WAS ANSWERED "NO". THIS SHOULD HAVE BEEN ANSWERED AS "YES" AND THAT THE DEVICE WAS RECEIVED BY MANUFACTURER ON 7/30/2015. ADDITIONAL INFORMATION: A MANUFACTURING RECORD REVIEW FOR THE PATIENT INTERFACE (PI) INTRALASE PROCEDURE PACK WAS PERFORMED; NO ASSOCIATED DEVIATIONS OR NON-CONFORMITY WERE GENERATED DURING THE MANUFACTURING PROCESS. ALL OPERATIONS PROCESSES DOCUMENTED IN THE MANUFACTURING RECORD WERE REVIEWED AND WAS CONFIRMED THAT ALL OPERATIONS RESULTS WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS AS PER OPERATION REQUIRED. A REVIEW OF THE MANUFACTURING CONTROLS SHOW THAT THE SYRINGE IS 100% INSPECTED FOR CRACKS, DAMAGES OR DEFORMATION AS PER THE REQUIRED MANUFACTURING CONTROLS. IN ADDITION, THE GRIPPER IS 100% VISUALLY INSPECTED FOR DAMAGE AND DEFORMATION AND IMPROPERLY SEATED GRIPPER / SEAL RINGS BEFORE VACUUM TESTING. THE GRIPPER IS INSPECTED FOR THE LOCKING CLIP TO BE IN THE CORRECT/OPEN POSITION AND VACUUM TEST IN PERFORMED ON THE UNIT IN ORDER TO PROVE THE SUCTION. THE GRIPPER/SYRINGE ASSEMBLY THAT WAS VACUUM TESTED TOGETHER IS PLACED AT THE TRAY ASSEMBLY PACKAGING. MANUFACTURING RECORD WAS REVIEWED AND THE DOCUMENTATION SHOWS THAT THE PURCHASE ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND NO DEVIATION OR ASSIGNABLE CAUSE WAS IDENTIFIED WHEN THIS BATCH WAS MANUFACTURED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PATIENT INTERFACE (PI) SUCTION RING MAY LOSE SUCTION DURING A PROCEDURE. LABEL COPY STATES CORNEAL FIXATION VACUUM LOSS CAN OCCUR. THERE ARE SEVERAL FACTORS THAT MAY CONTRIBUTE TO SUCTION ISSUES SUCH AS DOCTOR'S TECHNIQUE IN SQUEEZING THE PI CLIP TO SECURE THE SUCTION RING TO THE PI CONE AND PATIENT ANATOMY AFFECTING THE INTERFACE BETWEEN THE PATIENT'S CORNEA AND THE SUCTION RING. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED SUCTION LOSS AFTER THE LASER FIRED. THE LOSS OF SUCTION WAS 7 SECONDS INTO THE PROCEDURE AND PROCEDURE WAS ABORTED. THE ISSUE WAS DISCOVERED AFTER PATIENT APPLANATION. PATIENT WILL BE RE-SCHEDULED FOR A PHOTOREFRACTIVE KERATECTOMY AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512778 INTRALASE PATIENT INTERFACE HNO ABBOTT MEDICAL OPTICS PI-RET CP01873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention