Safety Alert for SINGLE USE DISPOSABLE CONTACT LENSES. All registrations granted by ANVISA.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
    1259
  • Date
    2013-05-09
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    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.
  • Reason
    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