Federal disease control experts and leading eye doctors have formally concluded that Bausch & Lomb’sReNu with MoistureLoc contact lens solution was the one contributing to an outbreak of potentially blinding fungal eye infections earlier this year.

But the researchers' report, to be published in The Journal of the American Medical Association on Aug. 23, 2006, says it remains unclear exactly how the product caused the acute fungal infections.

Meanwhile, an accompanying commentary made by two academic researchers, argues that additional studies are needed to property measure the safety of various brands of "multipurpose" lens care solutions on the market.  Like MoistureLoc, multipurpose solutions are used for cleaning, storing and moistening soft contact lenses, making them more convenient to use.

Bausch & Lomb's argument that a major factor in the outbreak was customers' failure to properly clean their lenses and regularly replace the storage solution was challenged by the research report.  “Practicing good contact lens hygiene is a prudent and common-sense measure for all contact lens wearers, irrespective of contact lens solution used," Dr. Douglas C. Chang, a fungal disease specialist at the Centers for Disease Control, who was lead author on the report, said in an e-mail interview. "However, the most important message for contact lens wearers is to stop using MoistureLoc, and throw out any MoistureLoc solution purchased before the recall."

The initial reported cases of the fungal eye infections appeared in Asia last year and peaked in the United States this spring, not long after Bausch removed MoistureLoc from the domestic market on April 13. One month later, Bausch announced a worldwide recall.

Consequently, the dramatic events caused the company's stock and profit forecasts to plunge.

In some ways, the journal article is remotely positive news for Bausch, saying the number of confirmed new cases of the infection has slowed drastically since the recall.

The analysis also found no evidence of unusual health risks associated with an older Bausch product, ReNu MultiPlus, which the company has promoted as a replacement for the MoistureLoc solution. Since the recall, the Bausch & Lomb has been counting on renewed growth from MultiPlus to rebuild its formerly prosperous lens care business.

Moreover, the company expressed satisfaction with the article. "We think the report confirms that Bausch & Lomb took the right action in the interests of consumer health and safety by recalling the MoistureLoc product, and that Bausch & Lomb can continue to recommend its ReNu MultiPlus solution with confidence," the company said in an e-mail response to questions about the report.

The basis for the data analysis in the medical journal data was on 164 confirmed cases of Fusarium fungus eye infections in the United States from the beginning of June 2005 to the end of June this year. The conclusion of the analysis showed that over one-third of the patients had suffered serious enough damage to one or both eyes to require corneal transplants.

Prior to the recall of the solution, about 2.3 million of the nation's 30 million soft lens wearers used MoistureLoc. The analysis, however did not say how many of the most seriously injured patients used MoistureLoc, but the product was used by a large majority of those reporting fungal eye infections.

The researchers found some minor evidence for the company's contention of users topping off lens care solution in contact lens storage cases instead of replacing the solution, which raised the risk of fungal infection. But they said that in other respects there was no difference between the practices of the people infected and those who remained healthy.

The study revealed just one confirmed infection in June, and Dr. Chang said last week that health care officials had "every indication that the outbreak was over."

But, he said, health authorities continue to hear sporadic, unconfirmed reports of the eye infections that appear related to use of MoistureLoc supplies which were purchased before the recall.

Bausch is a long way from putting their MoistureLoc troubles behind it.

Two weeks ago, the company said in a filing with the Securities and Exchange Commission that pretax profits this year would fall to $80 million or less, a 78 percent drop from last year and far below Wall Street's estimates. The expenses of the recall and efforts to rebuild market share are also predicted to hurt earnings and sales in 2007 as well.

The company is also facing numerous consumer lawsuits linked to the fugal eye infection outbreaks.

Bausch & Lomb's shares closed recently at $46.39, down 3 cents. Fusarium, typically found in tropical countries, is a widely distributed family of fungi. In the past, agricultural workers or others in rural areas who scratch an eye with a twig or some other plant harboring the fungus have been the most common victims of Fusarium infections.

The potential link between Bausch's products and Fusarium infections was first reported in Asia last year when health authorities in Singapore and Hong Kong noticed a surge in infections among wearers of soft contact lenses.

MoistureLoc, which Bausch initially introduced in the fall of 2004, was removed from several Asian markets in February this year following their outbreak. Shortly thereafter, Bausch began receiving reports of cases in the United States, including some among lens users in northern states where Fusarium infections are extremely rare due to the climate.

Bausch eventually concluded that MoistureLoc's formulation could create biofilms in some circumstances that would block the fungus from the sterilizing agent in MoistureLoc, which could allow Fusarium to colonize a lens case or bottle cap, the company said.

In May, Dr. Daniel G. Schultz, the director of the Food and Drug Administration Center for Devices and Radiological Health, said that the agency was "reasonably certain" that Bausch had provided a "good answer" to what had gone wrong. But the authors of the journal report said there was too much evidence lacking to identify the exact problem with MoistureLoc and that more research was necessary to determine such.

While the convenience and ease of multipurpose solutions appeals to consumers, some doctors fear the solutions make it more difficult to reliably sterilize lenses in comparison to systems that use a separate cleaning agent. In a prominent ophthalmology journal earlier this year, it is noted that in 25 percent of the Fusarium cases reviewed, doctors had at first mistakenly prescribed an anti-inflammatory treatment that is appropriate for bacterial infections but actually makes fungal infections worse.

Dr. Todd P. Margolis and Dr. John P. Whitcher of the Proctor Foundation for Research in Ophthalmology at the University of California, San Francisco, said there is a need for more rigorous study of the entire class of all-in-one lens care products.

Dr. Margolis said in an interview that there was some evidence that the number of Fusarium cases began to rise before MoistureLoc was first marketed.

There are many cases out there that haven't been fully investigated," he said.

If you or a loved one has been injured by the use of ReNu with MoistureLoc, please contact a Jim S. Adler & Associates personal injury attorney for a free evaluation of your potential claim.