CooperVision Drags Feet On US Contact Lens Recall

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.

Recalls and Alerts: October 7, 2011

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

United States

  • Allergy Alert: Prolab Nutrition Inc. recalls some Prolab® Pure Whey, Prolab® Advanced Pure Whey Protein, and Prolab® Whey Isolate Protein (various flavors and sizes), because the protein items may contain undeclared milk, wheat and gluten. The recalled products were distributed by retail stores, mail order and direct delivery in the following states, provinces and countries: Alabama; California; Connecticut; Florida; Georgia; Idaho; Illinois; Indiana; Iowa; Kansas; Maryland; Massachusetts; Michigan; Minnesota; Missouri; Montana; Nevada; New Hampshire; New Jersey; New Mexico; New York; North Carolina; Ohio; Oklahoma; Pennsylvania; South Dakota; Tennessee; Texas; Utah; Vermont; Virginia; Washington; West Virginia; Wyoming; Ontario, Canada; Australia; Malaysia; and Russia.
  • Food Safety Recall: Farmers All Natural Creamery (Wellman, IA) recalls Whole Milk (Plant #19888; Sell by October 22, 2011), because the milk may not have been properly pasteurized. The recalled milk was sold to four distributors: UNFI (Aurora, CO), UNFI (Lancaster, TX), Calma Optimal (Franklin Park, IL) and Natural Brands (Wood Dale, IL).

Canada

  • Food Safety Recall: La Maison de Campagne 6600 inc. (Saint-Jean-Baptiste, QC) recalls Pesto & Cie brand Pesto citronnelle/Lemon grass pesto (212 mL glass jars; all lots purchased before September 24, 2011), because the product was held without refrigeration before sale, and may present a health hazard.
  • Food Safety Alert/Recall: Toronto’s Medical Officer of Health warns the public not to consume the following recalled smoked salmon products, because they might be contaminated with Listeria and Salmonella: Strubs Danish Style Smoked Grav-Lox Atlantic Salmon (300g; Product code 09262011), Strubs Norwegian Style Steelhead Salmon, Sliced Smoked (200g packages; Product code 09192011) and Strubs Deli Choice Smoked Salmon Bits (300g; Product codes 09192011 and 09262011). The recalled smoked salmon products were processed in Toronto, but may have been distributed elsewhere in Ontario.

Europe

Asia, Africa and the Pacific Islands

  • Allergy Alert (Malaysia): Prolab Nutrition Inc. recalls some Prolab® Pure Whey, Prolab® Advanced Pure Whey Protein, and Prolab® Whey Isolate Protein (various flavors and sizes), because the protein items may contain undeclared milk, wheat and gluten. The recalled products were manufactured in the USA and distributed by retail stores, mail order and direct delivery in Malaysia.

Australia and New Zealand

  • Allergy Alert (Australia): Prolab Nutrition Inc. recalls some Prolab® Pure Whey, Prolab® Advanced Pure Whey Protein, and Prolab® Whey Isolate Protein (various flavors and sizes), because the protein items may contain undeclared milk, wheat and gluten. The recalled products were manufactured in the USA and distributed by retail stores, mail order and direct delivery in Australia.
  • Food Safety Recall (Australia): Davies Bakery Pty Ltd. recalls Bakers Life Multigrain Sandwich Sliced Bread (650g; Best before 12 OCT 2011), because the product may contain bits of plastic. The recalled bread was sold in Aldi stores in Victoria only.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

Did Your Supermarket Sell Colorado Cantaloupes? – Updated 10/4/11

I had another phone call from Auntie Anne yesterday evening (the last call was about ground turkey). This time she wanted to know whether Stop & Shop carried the Colorado cantaloupes recalled by Jensen Farms, Inc.

I had to tell her, “I don’t know.” (Oct 4th Update: Thanks to Jennifer (see comments), I can now tell Auntie Anne that Stop & Shop cantaloupes did not come from Jensen Farms)

FDA issued a Press Release on September 14th, warning consumers not to eat Rocky Ford Cantaloupes shipped by Jensen Farms. These cantaloupes are linked to the multi-state outbreak of Listeria monocytogenes that has infected more than 84 people and caused 15 deaths as of September 30th.

Jensen Farms has recalled the cantaloupes, which were shipped to Illinois, Wyoming, Tennessee, Utah, Texas, Colorado, Minnesota, Kansas, New Mexico, North Carolina, Missouri, Nebraska, Oklahoma, Arizona, New Jersey, New York and Pennsylvania. FDA advises that “further distribution is possible.” The recalled cantaloupes may be labelled as shown in one of these photos:

As usual, FDA has not issued a retail distribution list for this recall, leaving it up to Jensen Farms and its customers (food service distributors and retailers) to make that information public.

Here’s what the public has been told so far.

Jensen Farms, Inc. cantaloupes were supplied to the following grocery chains and foodservice distributors:

  • Albertson’s:- Colorado stores.
  • Aldi:- Aldi stores are located  in 31 states, primarily from Kansas to the East Coast.
  • Basila Produce:- A “macro-distributor” of Jensen’s cantaloupes based in Albuquerque, NM
  • Carol’s Cuts LLC:- A Kansas food processor, who supplied Carol’s Cuts Fruit Medley products to institutional food customers, including restaurants, in Overland Park, Kansas, Kansas City and Maryland Heights, Missouri and Omaha, Nebraska. The product was shipped to customers on August 26 and September 12, 2011.
  • King Soopers:- Sweet Rocky Ford Cantaloupe – Jensen Farms; Various sizes. King Soopers has stores in Colorado and Wyoming.
  • Safeway:- Jumbo Rocky Ford Cantaloupe from Jensen Farms; sold in Colorado, Nebraska, New Mexico (Aztec and Farmington), South Dakota and Wyoming between August 30 and September 6.
  • Select Express LLC (Idaho):- Jensen Farms cantaloupes were shipped to Select Express (a food distribution company). Because the melons were too ripe to be sold, they were donated between August 28th and September 2nd.
  • U.S. Foodservice:- “A trace‐back from secondary suppliers and processors found a few cases of whole and some “cut” product affected in two USF Distribution Centers in the West. A small number of customers affected have been contacted.”
  • Wal-Mart:- North Dakota, Colorado* and New Mexico. Although Walmart has not posted the recall notice on its website (as of September 18th), a Colorado couple has filed suit against Jensen Farms Inc. and Wal-Mart, alleging that they purchased a “…tainted cantaloupe at a Wal-Mart store on Razorback Road in Colorado Springs.” The cantaloupes may also have been sold in Walmart stores in other states.
  • Wegmans Buffalo (NY) area stores only:- Packaged Cantaloupe Chunks, Cantaloupe Slices, Gourmet Fruit Salad, Small Fruit Salad, Small and Large Fruit Salad with Pineapple, and Fruit Salad with Kiwi Fruit Trays (Best if used by September 4 to September 11), sold in the produce departments of Buffalo-area stores between August 31 and September 11. The packages were supplied to Wegmans by Fruit Fresh Up, of Depew, NY.
  • Whole Foods Market:- In some New Mexico and Colorado locations. Notwithstanding these linked reports, Whole Foods believes that it was NOT supplied with Jensen Farms, Inc. cantaloupes.

*Based on information supplied by Bill Marler

The following grocery chains and foodservice distributors did NOT procure cantaloupes from Jensen:

Information from other government agencies:
  • West Virginia Department of Agriculture: West Virginia Commissioner of Agriculture Gus R. Douglass is warning consumers that a recall on cantaloupes includes products shipped to nearby states Pennsylvania and Tennessee, and that shoppers should make sure that any cantaloupes purchased in those states are not part of the recall. One outbreak case of Listeria monocytogenes has been confirmed in West Virginia.
  • Canadian Food Inspection Agency: No cantaloupes implicated in the U.S. recall have been shipped to Canada. Canadians who are considering purchasing cantaloupe when travelling in the U.S. are urged to monitor the recall on the United States Food and Drug Administration’s website.
  • Abu Dhabi Food Control Authority: No cantaloupes implicated in the U.S. recall were shipped to the United Arab Emirates.

Finally, this is a list of 25 states which were supplied directly with cantaloupes by Jensen Farms: Arizona, Arkansas, Colorado, Idaho, Illinois, Indiana, Kansas, Louisiana, Minnesota, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Dakota, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Wisconsin, and Wyoming.

FDA has determined that cantaloupes were not shipped directly to California, North Carolina, Ohio or Virginia. Nevertheless, some redistribution of cantaloupes into these and other states may have occurred. None of the recalled cantaloupes were exported.

I’ll continue to update these lists as more information becomes available.