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.