CooperVision Expands Contact Lens Recall

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.

Lab Error Triggers Product Recall

There’s a third-party contract lab located somewhere in Canada that needs to review its Good Laboratory Practices and lab sanitation protocols.

On October 5, 2011, the Canadian Food Inspection Agency (CFIA), in conjunction with Foodfest International 2000 Inc., warned the Ontario public that Strubs ready-to-eat Danish Style Smoked Grav-Lox Atlantic Salmon (Lot code 09262011) should not be consumed.

The Grav-Lox, according to CFIA, might be contaminated with Salmonella. Foodfest International 2000 Inc. (the distributor) recalled the offending product.

That was one month ago.

Today, CFIA rescinded its Health Hazard Alert, and advised the public that the Strubs Grav-Lox did NOT present a health risk from Salmonella.

Why the reversal? Because, according to CFIA, the lab responsible for reporting the initial Salmonella-positive result found that “...the Salmonella positive result was in fact a false positive, attributed to laboratory cross contamination.”

Now, I’ve worked in – and managed – several microbiology labs in my professional life. And I’m here to tell you that the LAST thing that should happen in a professionally run lab – whether government, in-house company, or third-party lab – is laboratory cross contamination.

Aseptic technique and assiduous attention to proper lab sanitation procedures are fundamental to the production of dependable lab results. So is the routine use of positive control and negative control sample analysis.

The company for whom the third-party lab did its analyses should have three questions for the lab’s management:

How did the lab cross-contamination happen?
Why did it take a full month for the cross-contamination to be discovered?
How will the lab change its procedures to ensure that the same thing doesn’t happen again?

I don’t know who hired the third-party lab; it could have been either Strubs or Foodfest (CFIA maintains its own labs). But, if I was the one who hired that hapless excuse for a professional lab, I’d be looking for a replacement, ASAP.

Botulism Alert – Finland, Germany, United Kingdom and USA

Italian olives tainted with botulinum toxin sickened two members of a Helsinki family last week.

Both individuals reported having eaten Gaudiano Organic Olives Stuffed with Almonds. Lab tests confirmed that the jar from which the two patients had eaten the olives contained botulinum toxin.

The tainted olives were packed in 314ml glass jars, with a best before date of 09/2012. They were imported into Finland by Kespro as early as September 2010. The olives were sold in Finland to K-food stores KCM Big Apple (Espoo), KCM Jumbo (Vantaa) and KSM South Centre (Rovaniemi), and to a few restaurants.

The olives have been withdrawn from sale in Finland, and consumers who purchased this product are asked to return it to the store.

Germany’s Federal Office for Consumer Protection and Food Safety has learned that some of these olives also were distributed in Germany, and is asking its citizens to dispose of any of the implicated jars of olives “with household waste”.

According to a notice posted October 21, 2011 on the Rapid Alert System for Foods and Feeds (RASFF) and updated this morning (October 24th), these olives also were distributed to the United Kingdom and the USA. So far, neither the U.S. Food and Drug Administration nor Britain’s Food Standards Agency has issued a Consumer Alert or a public health advisory of any sort.

eFood Alert Advisory to Consumers in Finland, Germany, the United Kingdom and the USA:

Check your pantry for Gaudiano Organic Olives Stuffed with Almonds (Product of Italy; Best before 09/2012), and discard the product in a safe manner. DO NOT TASTE THIS PRODUCT. If you have consumed even a tiny amount of this product and begin to experience any symptoms of botulism, including blurred vision or difficulty swallowing, seek immediate medical attention.