CooperVision is resisting a request from FDA to broaden its notification of contact lens problems, according to an article by JoNel Aleccia of msnbc.com.
The company issued a news release on August 19, 2011 to announce the recall of Avaira® Toric contact lenses, which was initiated due to “…the unintended presence of a residue on certain lenses,” and posted a recall page on the CooperVision website.
Although CooperVision claims to have notified retailers – including Costco, Walmart, and LensCrafters, among others – not a single Avaira® Toric retailer in the US appears to have posted the recall notice on its website. Only Costco Canada has posted such a notice – advising its customers that Encore100 Toric contact lenses (a CooperVision brand) were recalled.
Since the August recall announcement, I have received injury reports from more than twenty eFoodAlert readers. The latest reports, which were posted only this morning, describe problems with Frequency 55 Toric lenses – also a CooperVision brand:
From Carol in Pennsylvania – I live in Pennsylvania and purchased Frequency 55 Toric lenses from 1-800-contacts. This was in August/september 2010. I had hazy vision in one of my eyes, and ended up in the emergency room with a corneal abrasion. I also experienced about a month later the same issue in my other eye. Why isn’t Cooper Vision recalling Frequency 55 lenses as well. They have the exact same issue.
From Brian C. (no location) – I had the exact same issue with my left eye and Frequency 55 Toric lens that just happens to be made by CooperVision. I have not seen any mention of this brand in any media. I suffered a swollen eye, discharge, excruciating pain in my eye. I was given drops to clear the issue. This happened 2 months in a row. My doctor looked at me like I was crazy when I said that something is wrong with the lens. It happened the first day of the month for 2 months straight when I changed my contacts. It began with a cloudy spot in my vision in the morning and then an escalating amount of discomfort through the day and finally by the end of the day I could barely keep my eye open. Unfortunately, I didn’t have a spare lens case around or my glasses when I was at work.
FDA certainly thinks that the recall notification was inadequate. Morgan Liscinsky of the FDA Office of Public Affairs, informed me by email today that the agency believes a public recall notification is called for.
“As it stands,” Liscinsky stated, “the FDA believes that public notification of this recall is needed and has been in discussions with CooperVision regarding a firm-issued press release. Absent prompt and adequate communication by CooperVision, the FDA may independently share its concerns about Avaira Toric contact lenses.”
Liscinsky added that “…as part of its recall processes, the FDA regularly investigates whether affected devices should be added to an ongoing recall. When the FDA identifies such devices, it works with the devices’ manufacturers and distributors on appropriate recall strategies.”
FDA has the authority under the Code of Federal Regulations to mandate a recall of medical devices – including contact lenses – but only under specific circumstances and after following several time-consuming procedural steps. In practice, the mandatory recall process is too cumbersome to be used, except in extreme cases.
It’s time for FDA to “independently share its concerns” and issue a Consumer Alert about Coopervision’s Toric contact lenses.