Events

Safety Alert for MILLENNIUM Microsurgical System (Anvisa Reg: 10196150071) and STELLARIS Microcirurgical System (Anvisa Reg: 80136060123).

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

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
    1010
  • Date
    2010-03-18
  • 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
    According to the company, the incidents caused by the defect may be high risk, but to date there has been no report or complaint about Bausch & Lomb products marketed in Brazil or any other country.
  • Reason
    Model of ac power cord presenting a defect, which can cause sparks, carbonization and fire of cables.
  • Action
    Bausch & Lomb will replace the power cord at the user's request and / or during regular maintenance of the equipment.

Device

MILLENNIUM Microsurgical System (Anvisa Reg: 10196150071) and STELLARIS Microcirurgical System (A...

Manufacturer

Bausch & Lomb.