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.