BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT LIO

    MDR report key: 3820673 · Received April 10, 2014

    Report

    Report Number
    2028159-2014-00635
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. A SUPPLEMENTAL MDR WILL BE FIELD AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.(B)(4)

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE LASER EMBEDDED IN THE SYSTEM DID NOT WORK DURING A VITRECTOMY PROCEDURE. THE SYSTEM WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216661 PUREPOINT LIO LASER INDIRECT OPHTHALMOSCOPE HQF ALCON - IRVINE TECHNOLOGY CENTER PUREPINT LIO NA

    Patients

    Seq Age Sex Outcome Treatment
    1