BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREPOINT LASER

    MDR report key: 6000043 · Received October 5, 2016

    Report

    Report Number
    2028159-2016-04508
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 5, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED THAT THE LASER WAS CALIBRATED HOWEVER THE SURGEON WAS NOT SATISFIED WITH THE PERFORMANCE. THE PROCEDURE WAS ABORTED AND WILL BE COMPLETED AT A LATER DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652265 PUREPOINT LASER LASER, OPHTHALMIC HQF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention