Events

Safety Alert for Test lens kits

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by IM manufacturer unknown..

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 Number
    1
  • Date
    2016-04-22
  • Event Country
    Lithuania
  • Event Source
    MH
  • Event Source URL
    http://www.vaspvt.gov.lt/node/115
  • Notes / Alerts
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 recall data from the U.S. and Lithuania.
  • Extra notes in the data
  • Reason
    Neither the label nor the packaging nor the instructions for use bear the ce conformity marking (does not comply with the requirements of mn 4: 2009 38 and 39); there is no data about the manufacturer and the manufacturer's authorized representative in the eea (does not meet the requirements of mn 4: 2009 clause 14.3.1); batch / serial number not specified (not in compliance with mn 4: 2009, annex 1, clause 14.3.4).
  • Action
    Disallowed to market

Device

Test lens kits

Manufacturer

IM manufacturer unknown.
  • Manufacturers representative
    UAB Neurovita
  • Source
    MH