Events

Retiro De Equipo (Recall) de Device Recall Alcon 23G NonValved Trocar Cannula and Infusion Cannula

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 Research, LTD..

¿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
    62419
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2470-2012
  • Fecha de inicio del evento
    2012-05-29
  • Fecha de publicación del evento
    2012-09-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110462
  • 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
    Cannula, trocar, ophthalmic - Product Code NGY
  • Causa
    This medical device correction is related to alcon products that present a 23g non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23g non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.
  • Acción
    Alcon sent an Urgent a Voluntary Medical Device Correction letter on May 9, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed NOT to use the affected product, instead customers should use a 1-Count Valved Trocar Cannula and to complete and immediately return the Medical Device Correction Response Form to Alcon via fax at: (817) 916-9087 or email to: ReplacementCannulas@alconlabs.com. For questions customers should call 1-800-862-5266.

Device

Device Recall Alcon 23G NonValved Trocar Cannula and Infusion Cannula
  • Modelo / Serial
    1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828, 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814, 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065. 7) 23G Small Parts Kit - 8065750842. Complete list of lot numbers will be provided with recall recommendation.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
  • Descripción del producto
    This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. || Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.
  • Manufacturer
    Alcon Research, LTD.

Manufacturer

Alcon Research, LTD.
  • Dirección del fabricante
    Alcon Research, LTD., 9965 Buffalo Speedway, Houston TX 77054-1309
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    USFDA