Events

Retiro De Equipo (Recall) de Device Recall LADAR6000

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 Refractive Horizons, 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
    37605
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0854-2007
  • Fecha de inicio del evento
    2007-02-21
  • Fecha de publicación del evento
    2007-06-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51005
  • 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
    Excimer Laser System - Product Code LZS
  • Causa
    Observed 'central islands' in patients following custom myopia laser procedures using the ladar6000 excimer laser. (on may 11, 2007, alcon notified consignees that the device software programs for customcornea myopia and customcornea myopia with astigmatism of the device would be deactivated).
  • Acción
    Consignees were notified of the recall via two letters. On Feb. 21, 2007, consignees were requested to immediately stop performing all custom cornea myopia procedures and to return an acknowledgement card indicating they have received the alert and understand the required actions. On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated. After meeting with CDRH's Office of Compliance on August 27, 2007, the recalling firm committed to total product removal of the device. Notification will begin in Sept 2007 and will be made by personal visits to each consignee.

Device

Device Recall LADAR6000
  • Modelo / Serial
    All serial/lot numbers of the LADAR6000
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-including USA, Czech Republic, Spain, Australia, Italy, Hong Kong, Vietnam, Singapore, South Korea, and Canada
  • Descripción del producto
    LADAR6000 Excimer Laser System
  • Manufacturer
    Alcon Refractive Horizons, Inc.

Manufacturer

Alcon Refractive Horizons, Inc.
  • Dirección del fabricante
    Alcon Refractive Horizons, Inc., 2800 Discovery Dr, Orlando FL 32826-3010
  • Source
    USFDA