Events

Safety Alert for CONSTELLATION VISION SYSTEM; Registration 80153480085; CULVER CHANGE SYSTEM - Registration 80147540177. Lots: Attachment - Distribution Map

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ALCON LABORATÓRIOS DO BRASIL LTDA.; ALCON LABORATORIES, INC.

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
    1667
  • Date
    2015-08-20
  • 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's statement, the loss of intraocular fluid through a cannula or sclerotomy during surgery can cause fluctuations in intraocular pressure. To avoid changes in intraocular pressure (IOP), use of the IOP control feature of the CONSTELLATION® Vision System can be used during surgery, or a plug can be inserted into the valve cannula.
  • Reason
    The company alcon has identified that some specific batches of valve cannulas have the possibility to leak through its format. the product is sold as a single item or as part of the constellation® equipment kit.
  • Action
    The company that holds the registration in Brazil will take corrective action providing individual plugs to be used with the valve cannula, in cases where an excessive leak is identified during the use of the affected kit. For more information, contact the company. Phone: (11) 3732-4023

Device

CONSTELLATION VISION SYSTEM; Registration 80153480085; CULVER CHANGE SYSTEM - Registration 801475...

Manufacturer

ALCON LABORATÓRIOS DO BRASIL LTDA.; ALCON LABORATORIES, INC
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    ANVSANVISA