BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1891049 · Received October 29, 2010

    Report

    Report Number
    2028159-2010-02099
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVAL. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL 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 LIKELY A LOOSE TIP DUE TO THE SURGEON NOT TIGHTENING THE PHACO TIP SUFFICIENTLY. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED, THE PHACO TIP WAS LOOSE. THE NURSE STATED, THE SYSTEM WOULD PRIME AND TUNE THE HANDPIECE WITH NO PROBLEMS NOTED. THE NURSE STATED THAT AT THE END OF TUNING, THE TIP WAS LOOSE. WHEN THE SURGEON STEPPED ON THE FOOTSWITCH, THE TIP WOULD LOOSEN COMPLETELY. THE COMPANY SERVICE REPRESENTATIVE WAS ON SITE SERVICING ANOTHER SYSTEM. ADDITIONAL INFO RECEIVED FROM THE COMPANY SERVICE REPRESENTATIVE STATED, THE SURGEON WASN'T TIGHTENING THE PHACO TIP SUFFICIENTLY. THE COMPANY SERVICE REPRESENTATIVE REVIEWED THIS WITH THE SURGEON. THE PHACO TIP WAS TIGHTENED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CASE WAS DELAYED 15-30 MINUTES WHILE TROUBLESHOOTING THE ISSUE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK