BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3112032 · Received May 7, 2013

    Report

    Report Number
    2028159-2013-00840
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SERVICE REPORT INDICATES THAT THE CUSTOMER EXPERIENCED LOW PHACO POWER AND OCCLUSION ON THEIR SYSTEM. THE FACILITY'S BIOMEDICAL TECHNICIAN CALLED THE COMPANY TECHNICAL SUPPORT SPECIALIST (TSS) TO ASSIST WITH TROUBLE SHOOTING. THE BIOMEDICAL TECHNICIAN IS TESTING THE SYSTEM AND STATED TO HAVE FOUND A TEAR IN THE HANDPIECE CABLE INSULATION AND EXPOSED WIRES. THE TSS ADVISED THE CUSTOMER TO CEASE USE OF THEIR HANDPIECE. THE CUSTOMER NOTED THAT THEY WOULD FOLLOW-UP IF THE ISSUE PERSISTS. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED LOW POWER AND AN OCCLUSION OCCURRED DURING A CATARACT EXTRACTION PROCEDURE. THE HANDPIECE AND SYSTEM WAS EXCHANGED TO COMPLETE THE CASE. THERE WAS NO HARM TO THE PATIENT. THE CUSTOMER INDICATED THE HANDPIECE WAS INSPECTED AFTER THE PROCEDURE AND NOTED THE CABLE WAS TORN AND THE WIRES WERE EXPOSED. THE HANDPIECE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199912 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OZIL TORSIONAL PHACO HANDPIECE