BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2818695 · Received October 31, 2012

    Report

    Report Number
    2028159-2012-01712
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 29, 2012
    Report Date
    October 1, 2012
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SERVICE REPORT INDICATES THAT THE CUSTOMER REPORTED SYSTEM MESSAGE (SM) - "U/S HP FAILURE - HANDPIECE VOLTAGE LOW (SHORT CIRCUIT)." THE COMPANY REP CONFIRMED WITH THE CUSTOMER THAT THIS IS WHAT THE CUSTOMER REPORTED ISSUE WAS AND NOT WHAT THE CALL WAS INITIALLY OPENED FOR WHICH WAS AN ASPIRATION ISSUE. THE COMPANY REP EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED SM AND NOTED AN OCCURRENCE OF SM-"U/S HP FAILURE - POWER AMPLIFIER SUPPLY VOLTAGE" AS WELL. THE COMPANY REP REPLACED THE U/S CONTROLLER PCBA. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED PROBLEMS WITH THE VACUUM DURING A CATARACT EXTRACTION PROCEDURE. FOLLOWING A 15 MINUTE DELAY, THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1