BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4790272 · Received May 22, 2015

    Report

    Report Number
    2028159-2015-06116
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    November 23, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K120912
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    \ EVALUATION SUMMARY: THE HANDPIECE WAS RETURNED FOR EVALUATION. VISUALLY, THE HANDPIECES CONNECTOR CAP WAS DETACHED FROM THE HANDPIECE. NO FURTHER VISUAL ISSUES OBSERVED. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED HANDPIECE TO TEST FOR NONCONFORMITY. THE HANDPIECE HOWEVER WAS FOUND TO BE HIGHER THAN SPECIFICATION FOR THE GROUND RESISTANCE TEST. WHEN MEASURING GROUND RESISTANCE ON AN AGED HANDPIECE, IT IS OFTEN DIFFICULT TO ENSURE PROPER CONTACT FOR ACCURATE MEASUREMENT OF THE GROUND RESISTANCE. HOWEVER, A GROUND RESISTANCE THAT IS HIGHER SHOULD NOT CAUSE ANY PATIENT RISK. A FLOW TEST WAS PERFORMED TO TEST THE IRRIGATION AND ASPIRATION LINES OF THE HANDPIECE IN WHICH THE HANDPIECE WAS FOUND TO MEET SPECIFICATIONS. THE HANDPIECE WAS THEN CONNECTED TO A CALIBRATED SYSTEM IN WHICH IT WAS ABLE TO PRIME AND TUNE. A STROKE TEST WAS PERFORMED TO CHECK THE ULTRASOUND AND TORSIONAL STROKE LENGTHS AND BOTH WERE FOUND TO MEET PER SPECIFICATION. THE PHACO HANDPIECE WAS FOUND TO MEET SPECIFICATION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RECEIVED BY A COMPANY REPRESENTATIVE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A HANDPIECE DID NOT GIVE ANY VACUUM. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334375 INFINITI VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OZIL TORSIONAL PHACO HANDPIECE