How hard is it for a company to release a complete list of lot numbers for a recalled product?

In CooperVision’s case, it’s very hard.

CooperVision’s recent expansion of its Avaira® Toric contact lens recall to include certain lots of Avaira® Sphere was accompanied by the launch of a recall site where consumers around the world could find out whether their Avaira® lenses were part of the recall. That’s fair.

But even in today’s world, many consumers, especially in less developed countries, DO NOT HAVE computers or internet access. It makes sense, therefore, for CooperVision also to publish a list of affected lot numbers. I went searching for that list, and found it on the website of Brazil’s Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency).

When I randomly selected a few of the 16-digit lot numbers from that list and entered them into the CooperVision recall search engine for several different countries, I received the message “Your lenses are affected by the recall.” When I entered the same numbers into the CooperVision US recall search engine, the software cut off the last two digits of the 16-digit number and returned a message “Your lenses are not affected by the recall.”

I contacted CooperVision and requested a list of lot numbers recalled from the US market – and received the following message from Denise Powell, replying on behalf of the company:

The FDA will also be posting the lot numbers on their government site. The best thing to do is to direct consumers to the CooperVision website, http://www.coopervision.com/international-recall so they can enter in their specific lot number to see if they have lenses impacted by the recall. There is a photo illustration showing consumers where to find the lot numbers on the page.

Next, I contacted FDA spokeswoman Morgan Liscinsky, who replied with the following message:

We cannot provide advance notice of any information posted to the FDA website. You should obtain the most up-to-date list of lot numbers from CooperVision.

After this dizzying display of non-disclosure, I had a closer look at the 16-digit lot numbers and realized that the final four digits were date codes. Entering the 12-digit numbers from the Brazil list (sans date code) into the US search engine produced the message “Your lenses are affected by the recall.”

Therefore, anyone who wants to peruse what I believe to be the complete list of recalled Avaira® Sphere lots can access this list courtesy of the Brazilian government. Consumers in the USA should refer to the column heading “Packaged Lot” for the US 12-digit lot numbers. Consumers outside the USA should refer to the column heading “Captured Lot” for the international 16-digit lot numbers.

Anyone having difficulty accessing the Brazil web page is welcome to contact me directly and I’ll be happy to share a pdf file of the list by email.

CooperVision’s contact lens recall has expanded to include a second Avaira® product. The expanded worldwide recall affects 4.9 million Avaira® Sphere contact lenses that may be contaminated with silicone oil residue. FDA is aware of the expanded recall.

The presence of silicone oil residue on the contact lenses “… may cause hazy vision or discomfort, severe eye pain or eye injuries requiring medical treatment,” according to the company’s news release.

In August 2011, CooperVision quietly recalled a limited number of production lots of Avaira® Toric contact lenses due to a “residue” problem. The recall, which was expanded in late September to include additional production lots, affected consumers in the USA, Canada, Hong Kong, Australia, Spain, Germany and Italy.

The Avaira® Toric recall was not widely publicized via a US Food and Drug Administration Class I recall notice until October 14th, after repeated reports were published by eFoodAlert and after MSNBC.com carried an October 11th article by JoNel Aleccia.

Today’s recall announcement affects consumers in several countries worldwide. CooperVision will launch a web site on November 16th where Avaira® users will be able to determine whether their lenses are affected by the recall.

Although consumers have complained to FDA and to eFoodAlert about problems with other CooperVision contact lens brands – most notably, ProClear and Frequency 55 contact lenses – only Avaira lenses are included in the expanded recall. Silicone oil is not used in the manufacturing process for these other brands.

As of late October, FDA received at least 40 Adverse Event Reports on various CooperVision contact lenses. Twenty-three of the reports complained about Avaira® lenses, including two that specifically mentioned Avaira Sphere. Ten consumers cited problems with ProClear lenses, and three mentioned Frequency 55 Toric contact lenses. As of today (November 15th) eFoodAlert has received 44 complaints from wearers of CooperVision contact lenses, including Avaira, ProClear and Frequency 55.

Notwithstanding this complaint pattern, I was informed last month by Morgan Liscinsky of FDA that the agency was satisfied with CooperVision’s performance. “The FDA,” Liscinsky told me on October 27th, “does not have any information at this time that would indicate that this voluntary recall would be expanded to include other CooperVision contact lens brands.”

For links to prior eFoodAlert articles relating to the CooperVision contact lens recalls, please click on the Toric Recalls tab at the top of the page. I’ll be updating this list to include more information on the latest recall as additional details become available.