BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUREATE WORLD PHACO SYSTEM

    MDR report key: 3963158 · Received May 27, 2014

    Report

    Report Number
    2028159-2014-00930
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    March 16, 2014
    Report Date
    March 20, 2014
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS CUSTOM PAK LOT. REVIEW OF THE DHR (DEVICE HISTORY RECORD) INDICATES THE ORDER WAS BUILT TO SPECIFICATION. A SAMPLE IS EXPECTED, BUT HAAS NOT YET BEEN RECEIVED AT THE MANUFACTURING SITE FOR EVAL. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UPON FIRST USE OF THE KIT DURING THE PHACOEMULSIFICATION PORTION OF A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE EQUIPMENT DID NOT RECOGNIZE THE KIT ON THE FIRST PRIME, AND THE PT EXPERIENCED COLLAPSE OF THE ANTERIOR CHAMBER, THE KIT WAS EXCHANGED AND THE PROCEDURE WAS ABLE TO BE COMPLETED. THERE WAS NO HARM TO THE PT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310152 LAUREATE WORLD PHACO SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR LAUREATE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LENSX