Events

Retiro De Equipo (Recall) de Constellation Vision 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 Alcon Research LTD dba Alcon Laboratories, 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
    55648
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1931-2010
  • Fecha de inicio del evento
    2010-04-30
  • Fecha de publicación del evento
    2010-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91450
  • 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
    unit, phacofragmentation - Product Code HQC
  • Causa
    Alcon identified system performance and machine settings that may impact the infusion performance of the constellation vision system, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
  • Acción
    The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system. For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.

Device

Constellation Vision System
  • Modelo / Serial
    All lot/serial numbers
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    Constellation Vision System, Model: Constellation T, Catalogue Number: 8065751558 || The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
  • Manufacturer
    Alcon Research LTD dba Alcon Laboratories, Inc.

Manufacturer

Alcon Research LTD dba Alcon Laboratories, Inc.
  • Dirección del fabricante
    Alcon Research LTD dba Alcon Laboratories, Inc., 15800 Alton Pkwy, Irvine CA 92618-3818
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    USFDA