Events

Alerte De Sécurité sur CONSTELLATION VISION SYSTEM; Registration 80153480085; CULVER CHANGE SYSTEM - Registration 80147540177. Lots: Attachment - Distribution Map

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ALCON LABORATÓRIOS DO BRASIL LTDA.; ALCON LABORATORIES, INC.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1667
  • Date
    2015-08-20
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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
  • Société-mère du fabricant (2017)
    Novartis Ag
  • Source
    ANVSANVISA