The original three-paragraph recall notice was issued on Aug. 19. It suggested that relatively few contact lenses were involved and offered no specific information to consumers or to retailers.
The FDA confirms that it exchanged letters with CooperVision over the recall, although it has not yet made those letters public. That exchange apparently prompted yesterday’s new recall notice.
The firm yesterday said that within two weeks of the Aug. 19 recall, it sent worldwide recall notifications to customers and to eye care providers, included lot-number information on its web site, established a toll-free consumer hotline, instructed retailers to send back all Avaira Toric products, and provided retailers with patient-communication materials.
People can check to see whether their contact lenses are included in the recall by going to the Coopervision.com/recall web site or by calling 855-526-6737.
“As it stands, the FDA is currently evaluating the [new recall] notification and will advise CooperVision of any concerns that it raises,” FDA spokeswoman Morgan Liscinsky tells WebMD via email.
If the FDA isn’t satisfied, it may issue its own, more blunt recall notice. However, the FDA does not have the power to force a device or drugmaker to recall a product.
CooperVision says the problem with the Avaira Toric lenses is due to “the unintended presence of a residue on certain lots” of the lenses.
People who experience problems with the lenses should immediately stop wearing them and consult their eye-care provider. Those who used the product but do not have symptoms should contact CooperVision to see if their lenses are recalled. Recalled lenses can be returned for a refund at the place where they were purchased.