BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3140153 · Received May 29, 2013

    Report

    Report Number
    2028159-2013-01044
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 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
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY TECHNICAL SUPPORT SPECIALIST (TSS) TO ASSIST WITH TROUBLESHOOTING. THE TSS INSTRUCTED THE CUSTOMER OVER THE PHONE TO VIEW THE EVENT LOG SCREEN. THERE WERE NO EVENTS ON THE DATE OF THE REPORTED EVENT. THE CUSTOMER SUSPECTED THAT A BUTTON ON THE SYSTEM'S REMOTE WAS PRESSED DOWN, IMPEDING THE VACUUM FUNCTION OF THE SYSTEM. THE CUSTOMER WAS INSTRUCTED TO HOLD DOWN A BUTTON ON THE REMOTE TO SEE IF THE PROBLEM COULD BE IDENTIFIED. THE FACILITY DID NOT REQUEST SERVICE. 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. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PRIME AND NO VACUUM WAS EXPERIENCED WHEN SET AT 100 MMHG. ADD'L INFO WAS RECEIVED INDICATING THE EVENT OCCURRED DURING SURGERY. THE CUSTOMER INDICATED THAT SOMETHING WAS RESTING ON THE REMOTE AND THIS INTERFERED WITH SURGERY. THE SYSTEM WAS EXCHANGED TO COMPLETE THE CASE FOLLOWING A 15 MINUTE DELAY. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235783 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1