Safety Alert for Biomedics 1 day (55%) toric contact lenses

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by CooperVision.

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
  • Date
    2014-03-22
  • Event Date Posted
    2014-03-22
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: coopervision biomedics 1 day (55%) toric contact lenses it has come to our attention that medical device manufacturer, coopervision, has initiated a field safety corrective action concerning its biomedics 1 day (55%) toric contact lenses. the affected lot number is 10803500560. the manufacturer has identified a single lot of biomedics 1 day (55%) toric contact lenses that have an incorrect lens axis. the labelled specification for the lens axis is 180° instead of the actual 90° axis. the manufacturer advises users to quarantine and return the affected products. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 mar 2014.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: CooperVision Biomedics 1 day (55%) toric contact lenses
  • Manufacturer

Manufacturer