Events

Retiro De Equipo (Recall) de Orion IFP3D6

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Eurocrystal.

¿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
  • Fecha
    2000-04-10
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/lentilles-intra-oculaires-orion-ifp3d6--eurocrystal
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Notas adicionales en la data
  • Acción
    The director general. Vu. Book VIII of the Public Health Code, and in particular Articles L.793-1 and L.793-5-I. Vu. the eight reports of materiovigilance received between October 26, 1999 and February 28, 2000. Seen. the expert report of 8 February 2000. Seen. Mail No. 20000823 dated March 1, 2000, sent to the manufacturer for comments. Considering. that the reports of materiovigilance report nine opacifications of intraocular lenses Orion IFP3D6 manufactured, put on the market and distributed by the company Eurocrystal from March 17, 1999, intervened within 3 to 22 months after their implantation. Considering. to date, the origin of these opacifications, which have led to a decrease in the visual acuity of the patients, could not be determined. Considering. that these opacifications required the explantation of six lenses, and that this operation puts patients at risk. Considering. whereas, therefore, pending the determination of the causes of the opacifications and in the interest of public health, the implantation of these lenses should be suspended. DECIDE. ARTICLE 1e. : The manufacture, placing on the market, distribution, export and use of Orion IFP3D6 intraocular lenses manufactured by Eurocrystal - 3, avenue de l'Europe - Campus 2A - 31400 TOULOUSE, are suspended for a period of six months from the date of publication of this Decision. The Director of Medical Device Evaluation and the Director of Inspection and Facilities are responsible, each for his own part, for the implementation of this decision, which will be published in the Official Journal. of the French Republic. Done at Saint-Denis, April 10, 2000.

Device

Orion IFP3D6
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Eurocrystal

Manufacturer

Eurocrystal
  • Source
    LAANSM