BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON DUET

    MDR report key: 6134087 · Received November 29, 2016

    Report

    Report Number
    3004750704-2016-00031
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    October 27, 2016
    Report Date
    February 22, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 01/18/2017. DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION: THE SYRINGE UNIT WAS RETURNED WITH THE CANNULA GUARD ATTACHED, HOWEVER THE CANNULA WAS NOT RETURNED TO LIFECORE. FUNCTIONAL EVALUATION COULD NOT BE COMPLETED BECAUSE THE CANNULA WAS NOT RECEIVED. EVALUATION OF THE RETURNED SYRINGE WITH A STOCK CANNULA COULD NOT REPLICATE ANY ATTACHMENT ISSUES DUE TO THE LUER LOCK CONNECTION. THE CANNULA WAS ABLE TO FULLY ENGAGE WITH THE LUER LOCK. THE CANNULA DID NOT DETACH WHEN FORCE WAS APPLIED TO PULL THE CANNULA FROM THE SYRINGE. NO ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD BE IDENTIFIED BASED ON THE REVIEW OF THE BATCH RECORD AND RECEIVING INSPECTION REPORTS. THE INVESTIGATION SHOWS THAT THE RAW MATERIAL SYRINGES AND CANNULAS USED WERE FOUND TO BE ACCEPTABLE AND THAT THE FINAL PRODUCT LOT MEETS THE PRODUCT SPECIFICATIONS. SINCE THE ROOT CAUSE IS NOT LIKELY TO THE MANUFACTURING PROCESS, NO ACTIONS RECOMMENDED AT THIS TIME. THIS RECORD REVIEW DETERMINED COMPONENTS WERE AS INTENDED WHEN EVALUATED BY LIFECORE'S ROUTINE RECEIVING INSPECTION. LIFECORE WILL CONTINUE TO MONITOR AND TREND COMPLAINTS OF THIS TYPE. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ENDOCOAT HAD MALFUNCTIONED. THE CANNULA WAS ATTACHED BUT THE OPHTHALMIC VISCOELASTIC DEVICE (OVD) CAME OUT FROM THE SIDE DURING THE PROCEDURE. THE CUSTOMER HAD THE GUARD ON, SO THERE WAS NO PATIENT INJURY. THE CUSTOMER TRIED TIGHTENING THE CANNULA, BUT THE OVD STILL CAME OUT OF THE SIDE; THE CANNULA DID NOT COMPLETELY DETACH. THE CUSTOMER HAD TO USE A NEW PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784219 HEALON DUET OVDS LZP ABBOTT MEDICAL OPTICS 10-2200-10 026100

    Patients

    Seq Age Sex Outcome Treatment
    1