Category: recalls

CooperVision Recall Hits Contact Lens Users In 69 Countries

CooperVision’s Avaira® Sphere contact lens recall affects a far broader geographic audience than was hit by the earlier Avaira® Toric recall.

The Toric recall affected contact lens wearers in seven countries: Australia, Canada, Germany, Hong Kong, Italy, Spain and the USA. In contrast, the recalled Avaira® Sphere contact lenses were supplied to 69 countries in North America, the Caribbean, Central America, South America, Europe, Asia, Africa, and Oceania.

CooperVision has published an international website where consumers can find out whether their packages of Avaira® Sphere and Avaira® Toric contact lenses are affected by the recall. Anyone who wears Avaira® contact lenses and lives in one of the 69 countries should check the status of their lenses immediately.

I’m told by Denise Powell, speaking on behalf of CooperVision, that Avaira® Sphere contact lenses are sold under different brand names in certain countries. Contact lens wearers using any of the following brands should check the CooperVision international website to determine whether their lenses are affected: Ascend Evolve, Betaview 2 weekly, Clear Choice Premium Plus 14 Day, Easyvision Elite Fortnightly, Prevue Platinum, ProActive Premium, Softview Fortnightly Plus, Trio2 Premium 2 week, See and Save 2 Week, VisionPlus Fortnightly, Encore 100, and BioComfort XO.

Some of the countries affected by the CooperVision recall have posted recall notices with more specific details, including other brand names under which the recalled contact lenses are sold. Please follow the live links for more details:

  • Argentina
  • Aruba
  • Australia:- Avaira (enfilcon A) Sphere Contact Lenses. Also marketed under the brand names: Clear Choice Premium Plus 14 Day Sphere, Prevue Platinum Sphere, ProActive Premium Sphere, VisionPlus Fortnightly Sphere, Softview Fortnightly Plus Sphere, See and Save Premium 2 Week Sphere, Trio2 Premium 2 Week Sphere, Ascend Evolve Sphere, and Betaview 2 Weekly SphereEasyvision elite fortnightly Sphere
  • Austria
  • Barbados
  • Belgium
  • Brazil:- Avaira Sphere contact lenses (registration #80130430037). List of 104 affected lots.
  • Bulgaria
  • Canada:- Encore 100 contact lenses. Costco Canada reports that the recalled Encore 100 Sphere Contact Lenses were sold in Costco Canada warehouse stores between March 16 and October 12, 2011.
  • Chile
  • China
  • Colombia
  • Costa Rica
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Ecuador
  • Faroe Islands
  • Finland
  • France
  • Germany
  • Guatemala
  • Honduras
  • Hong Kong:- Avaira and BioComfort XO contact lenses; FreshKon Airis 1-Month, imported from Singapore and distributed by Oculus Optical (H.K.) Co., Ltd.
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Italy
  • Jamaica
  • Kazakhstan
  • Korea
  • Kuwait
  • Latvia
  • Lebanon
  • Luxembourg
  • Mexico
  • Netherlands
  • New Zealand:- Ascend Evolve, Avaira, Easyvision Elite Fortnightly, See and Save 2 Week Premium, Softview Fortnightly Plus, and VisionPlus Fortnightly
  • Nicaragua
  • Norway
  • Pakistan
  • Panama
  • Papua New Guinea
  • Peru
  • Poland
  • Portugal
  • Qatar
  • Republic of Ireland
  • Russia
  • San Salvador
  • Saudi Arabia
  • Serbia & Montenegro
  • Singapore:- Avaira and FreshKon Airis 1-Month contact lenses
  • Slovakia
  • Slovenia
  • South Africa
  • Spain:- Including Avaira, A Hisi, Albalens Silicone, Carla 3 Silicona, Cecop Silicone, Centro OP. Jose Manuel Marquez, Combisoft Nature, Delgado Espinosa Silicona, Dublan Silicona, Easygel Plus, Enfilcon DK100 Aspheric, Galindo, Gran Optica, Hidrancy Oxygen, HorizonT, Irco Vision, Lenso Active Hidro Silk, Lent Soft 4 Air, Lentigel Contact, Lentsport, Meca Opticos, Medifresh Elite, Miolent Q, My Vision Max, MyOptica, Only-You Hidrosilk, Optica Altavoz, Optica Avenida, Ramon Optica Hidramax, Soft Lens Oxygen, Verasilicon, and White light Silicone. List of 81 affected lots.
  • Sweden
  • Switzerland
  • Syria
  • Trinidad and Tobago
  • Tunisia
  • Turkey
  • United Arab Emirates
  • United Kingdom:- Avaira® Sphere contact lenses. List of 74 affected lots.
  • United States
  • Uruguay
  • Venezuela

Please check back periodically for additional updates to this recall information.

Last update: December 8, 2011

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.