Events

Retiro De Equipo (Recall) de EC3 Precision Aspheric Lens Intraocular Lens

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 Aaren Scientific, Incorporated.

¿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
    60962
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1077-2012
  • Fecha de inicio del evento
    2011-08-02
  • Fecha de publicación del evento
    2012-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106906
  • 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
    Intraocular lens - Product Code HQL
  • Causa
    The recall was initiated because aaren scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
  • Acción
    Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference. In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings. For further questions please call (909) 937-1033 ext. 108.

Device

EC3 Precision Aspheric Lens Intraocular Lens
  • Modelo / Serial
    Lot Number: 110617
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.
  • Descripción del producto
    Precision Aspheric Lens (PAL) Intraocular Lens || Model: EC-3 PAL, || Serial Number: 1169381106, 1169391106, 1169421106 || The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
  • Manufacturer
    Aaren Scientific, Incorporated

Manufacturer

Aaren Scientific, Incorporated
  • Dirección del fabricante
    Aaren Scientific, Incorporated, 4290 E Brickell St Ste A, Ontario CA 91761-1569
  • Empresa matriz del fabricante (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA