Events

Safety Alert for SKBM MICROCERATOMY - Registration ANVISA / MS: 10002390118. Composition: Console, Pedal, Handpiece (head, Steel Band, Motor, Blade), Suction Rings, Tube.

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.

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
    682
  • Date
    2002-11-25
  • 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
    Alcon is asking physicians to discontinue use of the product and to inform Alcon to remove the equipment. For more information, contact your local representative or directly with Alcon Laboratorios do Brasil Ltda at 11-3732-4103 or 11-3732-4119./////////////// ////////////////// - Brasilia-DF, 20.06.2003 - The company ALCON LABORATORIES DO BRASIL LTDA, informs that the recall process of the MICROCERATOMO SKBM product market, was completed.
  • Reason
    Degradation of the "epoxy" adhesive that supports the applanation window. this movement could represent a potential risk to the patient due to the lack of control over the depth of incision.
  • Action
    The company informs that it is conducting, voluntarily, the collection of the equipment.

Device

SKBM MICROCERATOMY - Registration ANVISA / MS: 10002390118. Composition: Console, Pedal, Handpiec...

Manufacturer

Alcon Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA