BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREPOINT

    MDR report key: 4101720 · Received September 15, 2014

    Report

    Report Number
    2028159-2014-01696
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    ALCON ¿ IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    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 CUSTOMER REPORTED THAT THE EQUIPMENT DID NOT TRIGGER THE LASER AFTER A VITRECTOMY PROCEDURE. THEY TRIED BOTH PORTS AND REPLACED THE OPTICAL FIBER AND IT STILL DID NOT WORK. THE CASE WAS NOT COMPLETED. THE LASER WILL BE PERFORMED WITH A SLIT LAMP AT A LATER DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570144 PUREPOINT LASER, OPHTHALMIC HQF ALCON ¿ IRVINE TECHNOLOGY CENTER PUREPOINT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other