Alerta De Seguridad para Centurion Vision System Technical Name: Centurion Vision System Registration Number ANVISA: 80153480089 Hazard Class: III Model Affected: Pack FMS Active, Basic (accessory); Pack FMS Active, 0.9mm Intrepid * Ultra ABS * Intrepid * Balanced 45º Serial numbers affected: 1799232H; 1794157H; 1801725H

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Novartis Biociência.; Alcon Laboratories, inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2102
  • Fecha
    2016-05-23
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    1. Review your inventory to determine if you have any affected lot units. 2. Immediately interrupt the use of affected units 3.Separe these affected products to ensure they will not be used 4. Alcon will contact you to arrange replacement of affected units if necessary 5.Please complete the form annex "Response Form", even if your facility does not have any units in stock. 6. Return the completed form to Alcon by e-mail: cs.brasil@alcon.com
  • Causa
    Alcon is conducting this voluntary withdrawal of medical device for specific batches of the fms active, basic pack and fms active pack, 0.9 mm intreoud ultra abs intrepid balanced 45 ° due to a possible presence of irregularity in the molding of the suction connector, which may result in reduction of vacuum in the suction line. the use of products from the affected batches of pack fms active, basic and pack fms active, 0.9 mm intrepid ultra abs * intrepid * balanced 45 ° can result in a small air leak and consequently a reduction in vacuum performance, leading to to an inability to achieve the maximum vacuum level and a reduction of the retention force at the distal end of the phaco tip.
  • Acción
    Field Action Code AG # 8500 triggered under the responsibility of the company Novartis Biociência. Company will collect for further destruction of the product.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA