BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2913559 · Received December 21, 2012

    Report

    Report Number
    2028159-2012-02026
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED AND EVALUATION IS IN PROGRESS. 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING MULTIPLE CATARACT SURGERIES, SEVERAL HANDPIECES INDICATED OCCLUSION IN THE ¿SCULPTING¿ PHASE. THE ISSUE ALSO OCCURRED WHEN THE HANDPIECES WERE HELD OUTSIDE OF THE EYE IN A CUP OF BSS (BALANCED SALT SOLUTION). CHANGING THE PHACO TIPS AND SLEEVES DID NOT RESOLVE THE PROBLEM. THE HANDPIECES WERE EXCHANGED TO COMPLETE THE CASES. THERE WAS NO PATIENT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 OZIL TORSIONAL PHACO HANDPIECE