BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALAS 532 EYELITE LASER SYS

    MDR report key: 4071537 · Received August 12, 2014

    Report

    Report Number
    2028159-2014-01496
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    GEX
    PMA / PMN Number
    K914334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE LASER DID NOT WORK WHILE PERFORMING TESTS. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479623 OPHTHALAS 532 EYELITE LASER SYS LASER INSTRUMENT, SURGICAL, POWERED GEX ALCON -IRVINE TECH CTR 8065500001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA