Cleveland, Ohio (PRWEB) November 21, 2011
The FDA has issued a Class I recall of CooperVision AVAIRA Toric Soft Contact Lenses (1). This is the most serious type of recall, meaning there is a reasonable probability that use of the product will cause serious adverse health consequences.
The AVAIRA contact lenses were recalled because of a silicone oil residue left on the lenses during manufacturing. So far, reported symptoms include hazy or blurry vision, discomfort, severe eye pain, eye injury requiring medical treatment, and loss of vision, but not everyone experiences the same symptoms (1)(2).
The affected contact lenses were manufactured between November 1, 2010 and August 3, 2011. CooperVision originally announced a “voluntary recall on limited lots of Avaira Toric contact lenses” (3). However, the number of affected lots has continued to increase since the original limited recall. According to the FDA, approximately 778,301 affected lenses were distributed (1).
Despite the scope of the problem, CooperVision only issued a limited recall to U.S. distributors and some healthcare professionals on August 19, 2011, which was followed by notice to foreign distributors a week later (1). CooperVision posted a press release on its website and filed it with the SEC, but it did not distribute the press release widely or send notification to consumers at that time.
After the FDA learned of the limited voluntary recall, it requested that CooperVision issue a broader statement to ensure that users were aware of the recall and threatened to take independent action, “Absent prompt and adequate communication by CooperVision.” according to an MSNBC news report (4).
CooperVision issued a press release in cooperation with the FDA on October 13, 2011 (5). On November 15, 2011, CooperVision expanded the recall again (6).
CooperVision has admitted that a manufacturing issue caused the unintended presence of residue on the lenses (3). After discovering the problem, CooperVision failed to provide adequate warning to consumers about the dangers of continuing to use Avaira Toric contact lenses and failed to adequately notify consumers that they may have already been exposed to the residue.
Spangenberg Shibley & Liber is investigating potential lawsuits against CooperVision related to injuries suffered from using Avaira contact lenses. These cases are complex, and an experienced medical device attorney will be able to evaluate your case and develop the necessary legal and scientific proof.
Spangenberg Shibley & Liber is a civil litigation trial team with experience representing victims of dangerous drugs and medical devices in state and federal court since the 1960s. The statute of limitations on your claim may already be running, so it is important to contact a contact lens recall lawyer promptly to protect your rights in the Avaira contact lens lawsuit.
3) Cooper Companies, Inc., Form 8-K, Filed with the United States Securities and Exchange Commission 08/19/11.