BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2081142 · Received April 14, 2011

    Report

    Report Number
    2028159-2011-00379
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND OBSERVED THE VITRECTOMY CONNECTOR NOT ALLOWING CONNECTION WITH THE VITRECTOMY PROBE. THE CUSTOMER REPRESENTATIVE REPLACED THE PNEUMATIC CONNECTOR, THEN TESTED THE SYSTEM AND FOUND IT MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED WHILE PERFORMING A VITRECTOMY, THE PORT ON THE UNIT WAS NOT HOLDING THE HANDPIECE TUBING SECURELY. ADDITIONAL INFORMATION RECEIVED INDICATED A POSTERIOR CAPSULE RUPTURE OCCURRED DURING THE CATARACT EXTRACTION PROCEDURE AND WAS UNRELATED TO THE EVENT. THE NURSE REPORTED THE ONLY PROBLEM WAS BEING UNABLE TO PLUG IN EQUIPMENT TO COMPLETE THE VITRECTOMY SURGERY. ANOTHER SYSTEM WAS USED TO COMPLETE THE CASE WITHOUT HARM OR INJURY TO THE PATIENT.

    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 KELMAN TIP| OZIL INFINITI TURBOSONIC AQUALASE HANDPIECE