Events

Retiro De Equipo (Recall) de Lipiflow Thermal Pulsation System

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
    75163
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0093-2017
  • Fecha de inicio del evento
    2016-09-13
  • Fecha de publicación del evento
    2016-10-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149494
  • 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
    Complaints related to an error condition occurring during patient treatment where the fipiflow system automatically stopped treatment after detecting a problem with the activator.
  • Acción
    The firm, TearScience, sent a "Medical Device Recall" letter dated September 9, 2016 to its consignees/customers on 9/13/2016. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the enclosed Acknowledgement and Receipt form by fax to (919) 882-9603, email to: Customerservice@tearscience.com or mail to TearScience, ATTN: CUSTOMER SERVICE RCL001, 5151 McCrimmon Parkway, Ste 250, Morrisville, NC 27560; to discontinue use of the product; to remove all a product with lot #201615220020 from your inventory; and call TearScience Customer Service at 919-459-4891 to return the product for above mentioned lot# and request new product for replacement. For any questions regarding this letter, please call (919) 459-4891 Monday through Friday, 8:30AM to 5:30PM, Easter Time.

Device

Lipiflow Thermal Pulsation System
  • Modelo / Serial
    Lot 201615220020
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution including states of: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA , WA, WI and Puerto Rico.
  • Descripción del producto
    LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 || The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
  • 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