Events

Safety Alert for BIPOLAR CLAMP ALCON. Lot under risk: 080614-91. Anvisa Registration n ° 80153480102.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Novartis Biociências SA.; 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
    1476
  • Date
    2014-12-02
  • 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 information submitted by the record holder, no adverse events or complaints have been reported so far. The use of non-sterile forceps during surgery can lead to a patient safety risk.
  • Reason
    Product not sterilized prior to dispensing.
  • Action
    Picking up the product for further destruction. Users should review their inventory, immediately stop and segregate the batch of the product under risk, identifying it to avoid inadvertent use.

Device

BIPOLAR CLAMP ALCON. Lot under risk: 080614-91. Anvisa Registration n ° 80153480102.

Manufacturer

Novartis Biociências SA.; Alcon Laboratories Inc
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    ANVSANVISA