BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3042895 · Received March 5, 2013

    Report

    Report Number
    2028159-2013-00323
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 8, 2013
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS ONE OF THE FIVE COMPLAINTS REPORTED FOR THIS ISSUE. THIS ONE OF FIVE COMPLAINTS FOR THE FINISH GOODS FOR THIS ISSUE. THE ORDER WAS BUILD AND RELEASED PER SPECIFICATION. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; VISUAL INSECT OR FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE CUSTOMER REC'D A TRAYLESS VERSION OF THE DEVICE. THE TRAYED EVERSION OF THE DEVICE ARE PLACED INSIDE OF A PLASTIC TRAY - THE TRAYLESS VERSION DOES NOT CONTAIN THIS PLASTIC TRAY AND CONSUMABLE IS NOW PLACED IN A PLASTIC BAG. WHILE THE TRAYLESS DEVICE CONFIGURATION MAY HAVE BEEN CONTRIBUTING FACTOR TO THE CUSTOMER'S REPORTED COMPLAINT, A ROOT CAUSE FOR THE REPORTED DAMAGE COULD NOT BE IDENTIFIED. THIS IS DUE TO THE FACT THAT OTHER FACTORS SUCH AS THE CUSTOM PAK'S CONFIGURATION, ADD-AFTER PLACEMENT, OR SHIPPING DAMAGE COULD HAVE ALSO INFLUENCED THE TUBING TO BE KINKED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A BLOCKAGE IN THE TUBING OCCURRED DURING SURGERY. THE TUBING WAS EXCHANGED. THE PT IMPACT IS UNK. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94764 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INFINITI BASIC PAK