BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALAS 532 EYELITE LASER SYSTEM

    MDR report key: 3042920 · Received March 5, 2013

    Report

    Report Number
    2028159-2013-00316
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 16, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    GEX
    PMA / PMN Number
    K914334
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING A 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 CUSTOMER REPORTED THAT THE SYSTEM MESSAGE DISPLAYED DURING PHOTOCOAGULATION. THE SYSTEM WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94699 OPHTHALAS 532 EYELITE LASER SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX ALCON - IRVINE TECHNOLOGY CTR 8065500001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1