BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2180995 · Received July 7, 2011

    Report

    Report Number
    2028159-2011-00771
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    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
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE ONE RELATED REPORT FOR THIS SYSTEM. THE COMPANY REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SURGEON HAD DIFFICULTY WITH VACUUM DURING PHACOEMULSIFICATION. THE SURGEON TWISTED THE CORD A LITTLE AND IT IMPROVED ENOUGH TO FINISH THE CASE. THERE WAS NO DELAY AND THE SURGERY WAS COMPLETED WITHOUT ANY HARM TO THE PT. THEY REPORTED THAT THEY DID NOT FEEL THE HANDPIECE WAS CAUSING THE ISSUE BECAUSE THE SAME HANDPIECE WORKED SATISFACTORILY WITH ANOTHER SYSTEM.

    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