Events

Recall of Proclear Toric Soft Hydrophilic Contact Lenses

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Coopervision Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-01039-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01039-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Coopervision's investigation of complaints have identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. there is not likely to be 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.
  • Action
    Retailers (practitioners) are advised to stop any further patient order fulfilment of the affected lots of Proclear Toric lenses and quarantine them for returning it to Coopervision. Patients will be provided full refund for any affected product returned by them. This action has been closed-out on 17/05/2017.

Device

Proclear Toric Soft Hydrophilic Contact Lenses
  • Model / Serial
    Proclear Toric Soft Hydrophilic Contact LensesMultiple lot numbers manufactured in 2012ARTG number: 169193
  • Manufacturer
    Coopervision Australia Pty Ltd

Manufacturer

Coopervision Australia Pty Ltd