Retiro De Equipo (Recall) de Healon D

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 Advanced Medical Optics, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    ophthalmic viscosurgical device - Product Code LZP
  • Causa
    Endotoxin levels above specifications have been noted in some syringes tested for lot number ud30654 of the amo healon d ophthalmic viscosurgical device. endotoxin levels above the maximum usp level may be potential causes of an inflammatory response and/or tass in patients following surgery.
  • Acción
    On Thursday, October 30, 2008, AMO began distribution of an Urgent Device Recall Notice via Federal Express overnight delivery to the twenty-six (26) AMO Healon D OVD, Lot UD30654, customer accounts in the United States. The Urgent Device Recall Notice include& a facsimile reply form. The Recall Notice informed the customers that AMO has received reports that some physicians using lot number UD30654 of the AMO Healon D OVD have observed an inflammatory reaction in their patients at the one-day post-operative visit. The customers were asked to undertake the following actions: (1) STOP using and remove from your inventory all units of AMO Healon D OVD, Lot UD30654. (2) Complete the included Facsimile Form making sure to note on the Facsimile Form the Quantities of AMO Healon D OVD present in your facility to be returned to AMO and fax to AMO Customer Service at 714-247-8722 within the next three (3) business days. The customers were also informed that an AMO Customer Service Representative will be contacting them to assist with the return of product affected by this action. If they have AMO Healon DC OVD units to be returned as part of this recall event and have not been contacted by an AMO Customer Service Representative, please call our toll free number at 1-877-AMO-4LIFE (1-877-266-4543) so that we can arrange the return of the product.


  • Modelo / Serial
    Lot Number: UD30654
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide to: MA, NJ, NY, WV, NC, SC, KY, OH, IN, MI, MN, OK, TX, WY OR, WA and Puerto Rico
  • Descripción del producto
    AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size
  • Manufacturer


  • Dirección del fabricante
    Advanced Medical Optics, Inc., 1700 E Saint Andrew Pl, Santa Ana CA 92705
  • Empresa matriz del fabricante (2017)
  • Source