Events

Safety Alert for ReNu Plus - Multi-use solution with protein remover. Record. Anvisa nº 10196150015 - SEE UPDATES OF THIS ALERT IN THE FIELD DESCRIPTION OF THE CLASS.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Bausch & Lomb do Brasil.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    857
  • Date
    2007-03-08
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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.

Device

ReNu Plus - Multi-use solution with protein remover. Record. Anvisa nº 10196150015 - SEE UPDATES ...

Manufacturer

Bausch & Lomb do Brasil
  • Source
    ANVSANVISA