Events

Safety Alert for Proclear Toric Soft Hydrophilic 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
    2014-10-03
  • Event Date Posted
    2014-10-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141003.html
  • 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 proclear toric soft hydrophilic contact lenses the australia therapeutic goods administration (tga) posted a medical device safety alert concerning proclear toric soft hydrophilic contact lenses manufactured by coopervision. the manufacturer's investigation of the complaints received have identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. according to the manufacturer, there is no added medical risk to an incorrect axis lens use, since the patient will notice the blur and visual disturbance right away and report it to the practitioner. replacement of the lens with the proper power parameter in sphere and cylinder, and/or axis of astigmatism will alleviate the visual blur and disturbance. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01039-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 03 october 2014.

Device

Proclear Toric Soft Hydrophilic Contact Lenses
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Coopervision Proclear Toric Soft Hydrophilic Contact Lenses
  • Manufacturer
    Coopervision

Manufacturer

Coopervision