Events

Alerta De Seguridad para ACRYLIC LENS TECNIS 1 PART MODEL ZCB00. Registro Anvisa 80147060093. Products affected: products with the following expiration dates 05/2011, 06/2011, 07/2011, 08/2011, 09/2011 and 10/2011.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Vistatek Produtos Óticos S/A.; Abbott Medical Optics 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
    998
  • Fecha
    2009-11-23
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    According to information presented by the product registration holder, the lens problem was caused by a recent change in the production process, which has already been corrected to avoid further problems. The recall in question only affects Tecnis Model ZCB00 lenses with the expiration dates quoted in this alert (see Product Description field). Anvisa's Technovigilance Unit is monitoring this case.
  • Causa
    Possibility of the handles adhering to the lens, after insertion into the patient's eye. this situation may lead to further manipulation during surgery, which may involve injury to the patient's eye.
  • Acción
    The company Vistatek Produtos Óticos S / A (holder of the product registration in Brazil) has already begun issuing notification letters to the customers who purchased the affected lots. The actions recommended to health professionals are as follows: (1) Verify in your inventory the existence of affected products (see affected lots in the Product Description field); (2) If a product is found, segregate it, identifying it properly so that it is not inadvertently used; (3) Communicate the company (see Source Description field) by means of a specific form (available at www.xxxxx); (4) Send the problem product (s) to Vistatek S / A. If you work with this product but do not have the batches affected in your inventory, fill out the form anyway and send, stating that you do not have the batches affected.

Device

ACRYLIC LENS TECNIS 1 PART MODEL ZCB00. Registro Anvisa 80147060093. Products affected: products ...

Manufacturer

Vistatek Produtos Óticos S/A.; Abbott Medical Optics Inc.
  • Source
    ANVSANVISA