BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUREATE WORLD PHACO SYSTEM

    MDR report key: 2202153 · Received August 5, 2011

    Report

    Report Number
    2028159-2011-00909
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND CONFIRMED THE CUSTOMER REPORTED EVENTS. THE COMPANY REP REPLACED THE TOUCH SCREEN, FOOTSWITCH, VITRECTOR HANDPIECE, POWER DISTRIBUTION PRINTED CIRCUIT BOARD (PCB), PHACO CONTROLLER PCB, FLUIDICS MODULE, FLUIDICS CONTROLLER PCB, HOST PCB, AND POWER SUPPLY. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING CATARACT SURGERY, THE SYSTEM DISPLAYED A MESSAGE RELATED TO THE FOOTSWITCH. THE PT SUSTAINED A POSTERIOR CAPSULE TEAR. WHEN THE VITRECTOMY HANDPIECE WAS SET UP, THE HANDPIECE DID NOT WORK. THE VITRECTOMY AND THE IMPLANTATION OF AN INTRAOCULAR LENS WERE ABORTED. ADD'L INFO REGARDING THE PT'S CONDITION HAS BEEN REQUESTED, BUT THE CUSTOMER DECLINED TO PROVIDE ANY FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUREATE WORLD PHACO SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER LAUREATE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention