BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT

    MDR report key: 2092183 · Received April 27, 2011

    Report

    Report Number
    2028159-2011-00446
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REP REPORTED THAT EACH TIME THE LASER IS MOVED, THE DOCTOR'S FILTER BECOMES DISCONNECTED AND MUST BE RECONNECTED BEFORE EACH USE. NO PT WAS INVOLVED AND THERE WAS NO HARM TO ANY DOCTOR OR STAFF MEMBER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA