BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT

    MDR report key: 4152318 · Received October 2, 2014

    Report

    Report Number
    2028159-2014-01819
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CTR
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SITE VISIT WAS PERFORMED. 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 CUSTOMER REPORTED EXPERIENCING LOW LASER POWER. TIMING OF THE EVENT IS UNK. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613982 PUREPOINT LASER, OPTHALMIC HQF ALCON-IRVINE TECHNOLOGY CTR PUREPOINT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA