Posted by: foodbuglady | October 14, 2011

CooperVision Avaira® Toric Recall Goes Public

October 14, 2011.- Today – almost two months after issuing a “recall notification letter” to its US and Canadian distributors and health care practitioners, CooperVision’s recall notice finally appeared on FDA’s website.

The essential details of the formal recall notice are as follows:

  • Recall Class: Class I (Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.)
  • Date Recall Initiated: August 19, 2011
  • Product(s): AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 Soft Contact Lenses for Astigmatism. The lenses were manufactured from November 1, 2010 through August 3, 2011. Consumers wanting to determine whether their lot code was recalled can use the search box on the CooperVision recall web page at http://www.coopervision.com/recall or call the toll-free consumer hotline at 1-855-526-6737.
  • Reason for Recall: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Please refer to the Recall Notice for additional information and instructions.

As I reported yesterday, FDA has received a total of 42 “adverse reaction” reports from contact lens wearers. Only 15 of those 42 reports were associated with Avaira® Toric contact lenses. According to FDA spokeswoman Morgan Liscinsky, several other brands manufactured by CooperVision have been the subject of consumer complaints, including Frequency 55 Toric, Proclear, Sofmed, and Enfilcon A contact lenses.

Several eFoodAlert readers also have reported eye discomfort and injuries associated with wearing Frequency 55 and Proclear contact lenses, in addition to many others who experienced corneal abrasions after wearing Avaira Toric lenses.

While I am pleased and relieved to see that CooperVision finally has consented to issue a Class I Recall Notice, I can’t help wondering whether this would have happened without the story published by JoNel Aleccia of msnbc.com on October 11th.

I also wonder how much more time must pass before CooperVision acknowledges that their problem extends beyond the Avaira Toric brand.

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Responses

  1. I do not think the FDA is doing their job. My son is going blind from wearing ProClear Toric (omafilcon A) Soft Contact Lenses custom fit lenses. Eye doctor was taught how to properly fit the lenses and Coopervision did not tell him how to calculate the fit properly. So my son is going blind due to lack of commucation between coppervision and the eye doctor. The FDA still has not placed a recall on these lenses or forced coppervision to stop selling them.

  2. It’s not just the Avaira’s. My Frequency 55’s were bothering me all summer. I thought it was pollen or reformulated saline solution. The Coopervision website ask for a 14 digit Lot # but my box only has 12 digits, so i get no information. If you use any Coopervision’s other than Avaira and experience unusual discomfort, take the time to complain to the FDA form 3500. I’ve heard some people are going to the hospital, corneas are damaged…

  3. Thank you for your diligence in covering this story. I also do not believe Coopervision would have “come clean” with Jonel Allecia’s article. Mellisa Cotton

    • You’re welcome Mellisa. I’m glad that I was able to make a difference.

      Phyllis


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