BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE MINIATURE TELESCOPE

    MDR report key: 5611041 · Received April 27, 2016

    Report

    Report Number
    3005347768-2016-00002
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    March 17, 2016
    Report Date
    April 19, 2016
    Manufacturer
    VISIONCARE OPHTHALMIC TECHNOLOGIES LTD
    Product Code
    NCJ
    PMA / PMN Number
    P050034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING REPORT WAS RECEIVED FROM VISIONCARE'S SENIOR REGIONAL MANAGER WHO WAS PRESENT AND OBSERVED THE SURGERY: IN REGARD TO THE DETAILS OF THE SURGERY, THE RHEXIS WAS A BIT ON THE SMALL SIZE. I DON'T KNOW THE EXACT SIZE BECAUSE IT IS DIFFICULT TO ESTIMATE VIA THE MONITOR BUT I COULD CERTAINLY SEE THAT IS WAS SLIGHTLY SMALLER THAN WHAT I TYPICALLY SEE. DURING THE INITIAL ATTEMPT TO INSERT THE IMT,THE SURGEON ENCOUNTERED SOME DIFFICULTY GETTING THE LEADING HAPTIC INTO THE BAG. HE ABORTED THAT ATTEMPT AND PULED THE IMT BACK OUT. AFTER BRIEF PERIOD OF TIME, HE MADE A SECOND ATTEMPT AND IT WAS AT THIS TIME WHEN I RECOGNIZED THAT THE HAPTIC HAD BROKEN. THE HAPTIC WAS FULLY SEPARATED AND PARTIALLY EXTENDED OUT OF THE WOUND. THE IMT WAS REMOVED ALONG WITH THE HAPTIC, THE SECOND IMT WAS PREPARED AND EVENTUALLY WAS SUCCESSFULLY PLACED IN THE BAG. THERE WAS STILL SOME DIFFICULTY ENCOUNTERED WITH THIS SECOND IMT BECAUSE (I ASSUME) OF THE SMALLER RHEXIS. THE DEVICE WAS RETURNED TO VISIONCARE TECHNOLOGIES AFTER EXPLANT. THE DEVICE WAS INSPECTED UNDER VIDEO MAGNIFICATION OF 132X AND IT WAS SEEN THAT THERE WERE INDICATIONS OF MICRO CRACKS ON THE BASE OF BOTH OF THE HAPTICS, THE BROKEN HAPTIC AND THE INTACT HAPTIC. THE OTHER TELESCOPE PARTS WERE NOT DAMAGED. A REVIEW OF THE MANUFACTURING RECORDS (DHR) FOR THE DEVICE DID NOT REVEAL ANY NON-CONFORMITIES. THE SHELF LIFE AND TRANSPORT STABILITY TESTING CARRIED OUT INCLUDED FORCE TEST, COMPRESSION FORCE AND DYNAMIC FATIGUE AND LOOP STRENGTH TESTING. REVIEW OF THE LABELING SHOWED THAT DIRECTIONS FOR THE CORRECT HANDLING OF DEVICE ARE PROVIDED IN THE PROFESSIONAL USE. A DEVICE ASSEMBLED WITH A CARRIER FROM THE SAME BATCH AS THE CARRIER ON THE EXPLANTED DEVICE WAS EXAMINED AND NO SIGNS OF MICRO CRACKS WERE SEEN. BASED ON THE ABOVE INVESTIGATION, IT SEEMS THAT THE HAPTIC BREAK WAS DUE TO EXCESSIVE COMPRESSION FORCE BEING APPLIED TO THE HAPTICS.

    Description of Event or Problem · 1

    DURING THE INITIAL ATTEMPT TO INSERT THE IMT, THE SURGEOPN ENCOUNTERED SOME DIFFICULTY GETTING THE LEADING HAPTIC INTO THE BAG. HE ABORTED THE ATTEMPT AND PULLED THE IMT BACK OUT. SHORTLY THEREAFTER HE TRIED AGAIN TO INSERT THE IMT AND IT BECAME APPARENT THAT THE HAPTIC WAS BROKEN. THE HAPTIC WAS FULLY SEPARATED AND PARTIALLY EXTENDED OUT OF THE WOUND. THE IMT TOGETHER WITH THE HAPTIC WAS REMOVED. THE SECOND (BACKUP) IMT WAS PREPARED AND SUCCESSFULLY PLACED IN THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267231 IMPLANTABLE MINIATURE TELESCOPE IMPLANTABLE MINIATURE TELESCOPE NCJ VISIONCARE OPHTHALMIC TECHNOLOGIES LTD WA 2.7X 10642

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention