Events

Retiro De Equipo (Recall) de Device Recall Laser Indirect Ophthalmoscope (LIO) .

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 Iridex Corporation.

¿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
    79386
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1075-2018
  • Fecha de inicio del evento
    2018-02-27
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162191
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Causa
    It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
  • Acción
    Action Taken by IRIDEX: 1. A investigation was started immediately upon receipt of the returned devices from the Sloan Kettering complaint on November 3, 2017. CAPA 0125 was initiated to document the events, root cause, correction, corrective and preventive action and effectiveness of these actions. 2. A ship hold was initiated on November 15, 2017. 3.As described below, IRIDEX plans to notify customers and distributors that it is voluntarily recalling all models of the TruFocus LIO Premiere. 4. Public Warning A press release was prepared and sent out on February 23, 2018. For further questions please call (650) 962-8848 Ext. 3672

Device

Device Recall Laser Indirect Ophthalmoscope (LIO) .
  • Modelo / Serial
    Device Identity : 87300, 87301, 87302, 87303, 87304
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
  • Descripción del producto
    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) || The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.
  • Manufacturer
    Iridex Corporation

Manufacturer

Iridex Corporation
  • Dirección del fabricante
    Iridex Corporation, 1212 Terra Bella Ave, Mountain View CA 94043-1824
  • Empresa matriz del fabricante (2017)
    Iridex Corporation
  • Source
    USFDA