BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1791267 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01406
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    July 8, 2010
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM. THE FOOTSWITCH CABLE WAS TIGHTENED. ONE PHACO HANDPIECE WAS NOT RECOGNIZED BY THE SYSTEM WHEN TESTED. THE CUSTOMER WILL REPLACE THE PHACO HANDPIECE. THE SOFTWARE WAS UPGRADED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): ¿NO HARM/IMPACT TO PATIENT." (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): ¿INTERMITTENT PROBLEMS WITH FOOTSWITCH¿ (DEVICE STOPS INTERMITTENTLY). THE CUSTOMER REPORTED INTERMITTENT PROBLEMS WITH THE FOOTSWITCH. THE INCIDENT OCCURRED DURING SURGERY. THE NURSE HAD TO SWITCH OUT THE FOOTSWITCH. THE NURSE ALSO REPORTED PROBLEMS WITH THE HAND PIECES. THERE WAS A 10-15 MINUTE DELAY TO SWITCH OUT THE HAND PIECE. THE CUSTOMER STATED THERE WAS NO PATIENT INJURY OR CANCELLATIONS.

    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 UNK