Alerta De Seguridad para Viscoelastic Sodium hyaluronate (3%) AMO VITRAX II (Anvisa record: 80147060068), batches affected: 012936, 012937, 013627, 015753, 016935, 016937, 018475, 018476, 018949, 020184, 023246, 023343.

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
    997
  • Fecha
    2009-11-19
  • 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
    According to information from the manufacturer of the product (Abbott Medical Optics Inc.), the use of ophthalmic solution with pH above 8.5 can cause endothelial damage to the cells of the eye. According to the record holder, there is currently no adverse event information related to the problem. Anvisa's Technovigilance Unit is monitoring this case.
  • Causa
    The ph of the product is out of specification, exceeding the acceptability range (6.8 to 7.5). the use of a product with a ph above the acceptable range may cause harm to the patient.
  • Acción
    The company Vistatek Produtos Óticos S / A (holder of the registration of the product in Brazil) has already begun issuing letters of notification to the customers who acquired the affected lots, according to information provided by the company. The actions recommended to health professionals are as follows: (1) Check in your inventory the existence of affected products; (2) If an affected product is found (see Product Description field), 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 (contact the company if you did not receive one); (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. The affected products returned to the company will be destroyed.