Events

Retiro De Equipo (Recall) de Device Recall LipiFlow

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Tearscience, Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    76365
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1535-2017
  • Fecha de inicio del evento
    2017-01-30
  • Fecha de publicación del evento
    2017-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152977
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Eyelid thermal pulsation system - Product Code ORZ
  • Causa
    Labeling: the labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
  • Acción
    Tearscience sent an MEDICAL DEVICE LABELING CORRECTION/RECALL letter dated January 30, 2017. .Actions to be Taken by Customer: Within 10 business days of receipt of this letter, please take the following actions: 1) Read the enclosed Summary of Important Labeling Changes for the LipiFlow¿ System. 2) Complete the Acknowledgement and Receipt form at www.TSVerify.pmcprograms.com or return the enclosed completed form by email or mail. 3) If you have stored Activators in an environment that is not temperature controlled (without heat and air conditioning), discontinue use of these Activators and call TearScience Labeling Change Hotline at (844) 872-5658. For any questions regarding this letter, please call (844) 872-5658 Monday through Friday, 8:00AM to 6:00PM, Eastern Time. We want to thank you for being a valuable TearScience partner, and as always would like to thank you for your business, your trust, and your commitment to treating MGD. For further questions please call (919) 459-4831.

Device

Device Recall LipiFlow
  • Modelo / Serial
    Model number LFD-1000 and LFD-1100, All lots
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide)
  • Descripción del producto
    LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
  • Manufacturer
    Tearscience, Inc

Manufacturer

Tearscience, Inc
  • Dirección del fabricante
    Tearscience, Inc, 5151 McCrimmon Pkwy Ste 250, Morrisville NC 27560-5427
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA