CooperVision acknowledged today in a morning news release that the company has received complaints of severe eye pain from wearers of its Avaira® Toric contact lenses. The news release followed yesterday’s report of contact lens problems by msnbc.com’s JoNel Aleccia, based in part on information supplied by eFoodAlert.
The Company announced a recall of “limited lots of Avaira® Toric lenses” on August 19, 2011 due to what it then described as “a small number of complaints of temporary hazy vision,” and posted a web page where consumers could check to see whether their contact lenses were recalled.
The recall applied to contact lenses distributed to the USA, Canada, Australia, Hong Kong, Germany, Italy and Spain, according to the Hong Kong Department of Health – the first agency to alert the public to this recall. Australia, Italy and Spain also posted public recall notices on their respective government web sites. Neither the USA nor Canada have done so. Nor has Germany, as far as I have been able to determine.
According to the Spanish consumer alert, the recalled contact lenses were manufactured by CooperVision Manufacturing Ltd, in the United Kingdom.
CooperVision’s latest news release explains its recall actions as follows:
As part of the recall, CooperVision notified its customers and requested eye care practitioners contact their patients regarding this recall. Because CooperVision lenses are sold through distributors and eye care practitioners, communication efforts have been focused through these channels in order to most effectively reach lens wearers. Within the first two weeks of the initiation of the recall on August 19, 2011, CooperVision completed the following actions:
- Sent worldwide recall notifications to more than 9,000 Avaira Toric CooperVision customers.
- Contacted more than 7,000 U.S. eye care practitioners who have received or sampled Avaira Toric contact lenses.
- Issued a press release via GlobeNewswire from CooperVision’s parent, The Cooper Companies, regarding the voluntary recall of limited lots of CooperVision Avaira Toric lenses.
- Included information on the CooperVision website for lens wearers to easily and quickly check if their lenses are impacted (www.coopervision.com/recall), established a toll-free consumer hotline (1-855-526-6737), and included an informational notice on http://www.coopervision.com.
- Instructed authorized distributors to send back all Avaira Toric products – not just specific lot numbers – so that CooperVision could ensure that affected lenses were removed.
- Provided retailers and distributors access to patient communications materials – including post cards and e-mail messages – to send to Avaira Toric lens wearers impacted by the recall.
- Worked with eye care practitioners to specifically remove affected lots of Avaira Toric products, by providing them with more than 3,500 customized reports detailing affected lots specific to their location.
- Deployed customer care resources to answer questions from patients, and a specialized team of customer care representatives were made available to contact patients on behalf of eye care practitioners.
The efficient and effective implementation of this recall remains a priority for CooperVision.
How does this description square with the experiences of consumers? Ask Whitney from Texas, who had this to say:
I ordered my Avaira Toric lenses from Lensking.com on August 8th. After I received them, I put one set on right way. About 30 minute later, my vision began to see cloudy white. I thought I had eyes problem so I removed them and threw them away. A month later, on September 28th, I put on a new set. They were OK at first. About an hour later, my vision was cloudy again. My eyes were a little irritated but I could handle OK. My right eye was irritated more than my left eye. I was at work and I didn’t have my glasses with me. I had them on the whole day. When I got home, I removed them off. My right eye was so painful. A couple hours later, it was swollen and I couldn’t open my eyes. My brother took me to the doctor and the doctor said he didn’t know what causes it. He prescribed me pain antibiotic medication. The second day I went to see him again. This time he said “NO wonder I was so painful because my cornea torn and rolled back.” At this point, he still didn’t know what cause it. By Monday, the following week, I checked online to see if I can change to my old brand of lenses. Then I discovered Avaira Toric is recalled since August 19th (about a week after I received my order) but no one informed me. Sure enough, when I entered the lot numbers on Coopervision recall website, all my 3 boxes right eye lenses, are the recalled lenses.
And Dani, who described the following experience:
I just checked and we purchased the contacts for my husband in August, he has had problems with his eye since then. I can’t believe not one doctor mentioned this recall, I am going to call all three of them tomorrow. I did call coopervision today and they acted like it was no big deal and people were just experiencing minor discomfort…..that was not the case at all for my husband, he didn’t even care if the numbing drops caused blindness he just wanted the pain to stop. … My husband has had to miss work, and money is tight for us, we pay cash for our medical bills and we can barely afford food/gas with four kids right now, him not being able to see isn’t helping things for us?????
I have received numerous reports from readers who purchased their CooperVision lenses from Costco,Walmart, LensCrafters, Internet sites and their eye doctors. None of these readers were informed of the recall, either by their eye doctors or their retailers. Clearly, CooperVision’s recall procedure was painfully inadequate.
I’m told by Morgan Liscinsky of FDA that the agency is watching the situation closely. “The FDA is evaluating the notification that CooperVision issued today,” Liscinsky said in an email message, “and will advise CooperVision of any concerns that it raises. Failing resolution of those concerns, the FDA may issue separate public communication.”
CooperVision hasn’t said when it first learned of the severe eye pain that some of its customers have experienced. But, by September 27th, the company was aware of the complaints of scratched and torn corneas and severe eye pain. That’s the day when Molly Martin, a CooperVision representative, posted the following comment in response to my September 22nd report that FDA was aware of the contact lens recall:
CooperVision initiated a voluntary recall of certain Lots of Avaira Toric. While we do not actively monitor or participate in online blogs, we were informed of this one and felt important to provide more details which can be found at CooperVision.com. We ask Avaira Toric lens wearers to call our Consumer Customer Service Department to learn more, ask any questions and allow us to help, 1-855-5-COOPER, (1-855-526-6737) or email email@example.com. (Consumer Care hours of operation are 9:00AM – 5:00PM ET Mon-Fri).
Today’s CooperVision news release says that the company’s “…first priority is always the health and safety of all CooperVision lens wearers.” Christine Moench, Vice President, Global Regulatory Affairs and Quality Assurance, adds, “as such we responded quickly to complaints from our customers by initiating a voluntary recall. We want to ensure that all consumers are aware of this action and know where to go for more information.“
If this is true, why has CooperVision dragged its feet on issuing a public recall notice, as FDA has urged it to do?
And why does CooperVision continue to limit its public statements to Avaira® Toric contact lenses, when additional brands such as BioComfort XO (Hong Kong), Encore100 (Canada) and Lent Soft 4 Air Tórica (Spain) also have been identified in public recall notices?
And why are some consumers reporting the same problems with other brands of CooperVision contact lenses, such as Frequency55?
CooperVision still has a lot of explaining to do!