Alerte De Sécurité sur SINGLE USE DISPOSABLE CONTACT LENSES. All registrations granted by ANVISA.

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 N/A.

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
    1259
  • Date
    2013-05-09
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    The manufacturer of single-use disposable lenses advises in their instructions for use what the indications, contraindications, adverse reactions, warnings and precautions are when using the product. Failure to observe recommended care may lead to severe eye problems, leading in some cases to loss of vision. Continuous use, use beyond the limit recommended by the manufacturer (these are single-use lenses), use without observing the necessary hygiene precautions when manipulated, significantly increases the occurrence of adverse events. Single use disposable lenses should not be reused. When the product is purchased, the user should be advised to seek medical attention if signs such as redness, blurring or any other visual changes occur, and symptoms such as pain, discomfort, foreign body sensation, or any other symptoms. You should also be warned about the importance of following the guidelines provided by the manufacturer.
  • Cause
    When using the product without the manufacturer's instructions being followed strictly, serious adverse user events may occur.
  • Action
    Users of this type of product should be very careful about observing the instructions for use that accompany the product, avoiding the purchase of fractional products that do not have them.

Manufacturer

N/A
  • Source
    ANVSANVISA