Alerta De Seguridad para ReNu Plus - Multi-use solution with protein remover. Record. Anvisa nº 10196150015 - SEE UPDATES OF THIS ALERT IN THE FIELD DESCRIPTION OF THE CLASS.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bausch & Lomb do Brasil.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    Research by Bausch & Lomb indicates a correlation between color, iron content and the biocidal efficacy of the product. The data demonstrate that the product with a high iron content, which has not changed color, is still effective as a biocide, and it is only because the iron interacts with the PHMB (polyaminopropyl biguanide) that, over time, the color changes and exists the possibility of efficacy being reduced. In a contaminated environment, microorganisms potentially present in the lens after rinsing may not be effectively reduced by the use of a solution whose disinfecting efficacy is compromised.
  • Causa
    The renu plus product units, batches # gc 6030 and gc 6063, contain a larger amount of the iron element than provided in the final product. this may result in a change in the color of the solution in some vials and the expiration date of the product may change for less than two years - that is the regular validity of the product, due to the possibility of reducing its effectiveness over time.
  • Acción
    Bausch & Lomb advises that all distributors that have units of the products identified by batches GC 6030 and GC 6063 segregate and forward them immediately to the company unit in the city of Porto Alegre - RS. AB & L is carrying out, as a preventive action, the collection of these lots in the distributors and points of sale thus avoiding the commercialization of products still in stock.


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