BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALAS 532 EYELITE LASER SYSTEM

    MDR report key: 5661433 · Received May 17, 2016

    Report

    Report Number
    2028159-2016-02068
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Report Date
    May 18, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    GEX
    PMA / PMN Number
    K914334
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS REPLICATED. THE CENTRAL PROCESSING UNIT (CPU) ASSEMBLY WAS REPLACED TO ADDRESS THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE SYSTEM WAS MANUFACTURED ON MARCH 25, 2005. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A CPU ASSEMBLY. HOWEVER, HOW OR WHEN THE COMPONENT BECAME NONCONFORMING CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A LASER SYSTEM PRESENTED WITH A BLACK SCREEN. THE TIMING OF THE EVENT AND PATIENT IMPACT ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315796 OPHTHALAS 532 EYELITE LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other