Tag: Avaira Toric

Australia Confirms Global Avaira® Toric Contact Lens Recall

Australia’s Therapeutic Goods Administration (TGA) has posted this consumer recall alert:

30 August 2011

Specific packs of Avaira Toric contact lenses are being recalled by CooperVision Australia Pty Ltd after the company received complaints of temporary hazy or blurry vision and discomfort from wearers. This recall is part of a global voluntary recall of specific lots.

Laboratory tests have found that these symptoms were caused by a small amount of residue on the lenses. In all reported cases the symptoms were temporary and reversed after the contact lenses were removed. There have been no reported cases of permanent eye damage.

Australia’s eye care practitioners have been notified directly of the recall.

The TGA offers the following additional advice for consumers who may be using Avaira® Toric contact lenses:

  • Discontinue use of Avaira Toric contact lenses until you have checked the lot number.
  • Check whether or not the lot number of your product is included in the recall. This can be done by:
    • viewing the recall notice on the CooperVision website
    • contacting the CooperVision customer service line on 1800 722 310
    • contacting your eye care practitioner.
  • If your product is included in the recall, return it to your place of purchase for a replacement or a refund.
  • If you have experienced blurry vision or discomfort while wearing these contact lenses, and the symptoms have not resolved within two hours of removing the lenses, contact your eye care practitioner for further advice.
The recalled Avaira® Toric contact lenses were distributed nationally through eye care practitioners/facilities.

CooperVision Recalls Avaira® Toric Contact Lenses

In what can only be described as a stealth recall, CooperVision has recalled “limited lots” of its Avaira Toric contact lenses. In its August 19, 2011 news release, the company described the scope and reason for the recall as follows:

“This recall is limited solely to specific lots of Avaira Toric, and no other CooperVision product is involved in this recall.

The recall was initiated because of the unintended presence of a residue on certain lenses. The residue was identified after investigating a small number of complaints of temporary hazy vision. The manufacturing issue has been identified and a resolution is in process. It is anticipated Avaira Toric shipments will resume shortly, and inventory will return to normal levels by December 1, 2011.”

A list of affected lots was not included with the recall notice; instead, consumers are invited to enter the lot number from their product package on the Avaira® Toric recall web page. As far as the FDA website is concerned, as of today (August 23rd), the recall still does not exist.

What is especially curious about this recall is that the Hong Kong Department of Health (DOH) has advised the public that Coopervision Hong Kong has recalled all of the Avaira Toric and BioComfort XO Toric contact lenses distributed in Hong Kong. In addition, the Hong Kong DOH press release advises that Avaira Toric lenses have been recalled in the United States, Australia, Canada, Germany, Italy and Spain.

The CooperVision web site gives no information regarding in which countries the recalled contact lenses were sold. Nor have ANY of the countries mentioned in the Hong Kong press release alerted consumers to this recall.

Have the FDA, Health Canada and all of the other affected national regulatory agencies turned a blind eye to this safety recall? Or are they asleep at the switch?

Members of the public who wear Avaira Toric or BioComfort XO Toric contact lenses should consult their optometrists. Pronto.