On June 29, 2007, Bausch and Lomb’s Greenville contact lens solution plant passed inspection by the U.S. Food and Drug Administration (FDA). Renu MoistureLoc contact lens solution manufactured at the plant was recalled and discontinued last year after several hundred reports of Fusarium keratitis, a severe infection of the cornea, in Asia and the United States.

Then, in March 2007, the company recalled about 1.5 million bottles of its ReNu MultiPlus solution made at the same Greenville plant because levels of iron in the product were found to cause the cleaner to be less effective.

Source: “Company says contact lens solution plant clears FDA inspection,” WIStv.com, July 17, 2007.

Bausch & Lomb, the company forced to recall millions of bottles of contact lens solution last year after hundreds of users contracted keratitis infections and other personal injuries, announced a recall of a second brand of its contact lens solution on March 6, 2007. Twelve lots of ReNu MultiPlus multi-purpose contact lens solution are being recalled. No injuries related to this recall have been reported.

Certain lots of ReNu MultiPlus, a multi-purpose solution marketed for cleaning and storage of soft contact lenses, were recalled by the company after elevated levels of trace iron were found. The lots of recalled ReNu solution were made at the same Greenville, SC Bausch & Lomb plant where Fusarium bacteria was found to have contaminated the company’s ReNu MoistureLoc product.

Over 100 contact lens wearers contracted microbial keratitis during the fungal infection outbreak, which injured people in Singapore as well as the United States. The Centers for Disease Control (CDC) later found that the largest majority of users’ injuries were linked to the ReNu MoistureLoc product.

ReNu MultiPlus is a related product that was not recalled at the time of the outbreak, but was linked to some adverse event reports (Source: CDC Release, April 10, 2006). Bausch & Lomb is now recalling 12 lots of ReNu MultiPlus which were distributed in the U.S., Latin America, Canada, Korea, and Taiwan.

Recalled ReNu MultiPlus solution carries the expiration date “2008-03” on the bottle. Bausch & Lomb is advising contact lens wearers to discard any ReNu MultiPlus solution that may appear discolored.

Source: “Bausch & Lomb recalls second contact lens solution,” Reuters, March 6, 2007.

Two couples from Nashville, TN have filed separate personal injury lawsuits against Bausch & Lomb alleging its ReNu with MoistureLoc Multi-Purpose Solution product led to their contraction of the serious bacterial eye fungus Fusarium keratitis. ReNu with MoistureLoc was recalled in May 2006 after the Centers for Disease Control (CDC) confirmed over 180 cases of Fusarium keratitis across the U.S. linked to contact lens solutions.

John Richardson of Clarksville, TN, was diagnosed with Fusarium keratitis, a serious infection of the cornea, in February 2006. Fusarium, a bacterium normally found in soil, water and other organic matter, is rarely known to invade the eye but when it does it can cause permanent damage. Fusarium bacteria actually “invades the cornea,” according to Dr. Jeffrey Sonsino, an optometrist at the Vanderbilt Eye Institute. “One of the reasons it is so serious is because it is very difficult to treat.” Without lengthy treatment, the infection can permanently scar the cornea, leading to vision loss or even blindness.

Richardson was forced to undergo corneal transplant surgery in an attempt to save his eye and “restore some useful vision,” according to his personal injury lawsuit. He suffered permanent vision loss as a result of his exposure to Fusarium keratitis.

Kathy Binkley of Nashville, TN, 44, contracted Fusarium in the form of a “Fusarium corneal ulcer” in November 2005 and underwent a corneal transplant two months later. Since her injury she has suffered decreased, blurred and distorted vision, eye pain, headaches, and sensitivity to light, and may face permanent blindness.

Bausch & Lomb may be facing as many as 700 personal injury lawsuits related to Fusarium keratitis infections and other injuries related to ReNu with MoistureLoc. The CDC called ReNu with MoistureLoc “the potential root cause” of an outbreak of infections worldwide.

“It’s pretty conclusive that this outbreak was due to this product,” Dr. Sonsino said.

Sources: Jared Allen, “Bausch & Lomb eye infections, lawsuits, surface in Nashville,” Nashville City Paper, February 13, 2007; Ben Dobbin, “Bausch & Lomb sees 2006 revenue falling below previous guidance on slow recovery,” January 31, 2007, accessed February 13, 2007.

On November 6, 2006, the Food and Drug Administration (FDA) released a warning letter it sent to Bausch & Lomb Inc. after it found violations in the company’s Greenville, SC plant. The FDA inspected the plant following reports that some users of Bausch & Lomb’s ReNu with MoistureLoc contact-lens solution contracted a rare eye infection, Fusarium keratitis.

Bausch & Lomb announced a world-wide recall of the cleaning solution in May 2006 after announcing the product’s formulation, when combined with certain patient use patterns, may lead to an increase in risk of Fusarium keratitis, a fungal eye infection that can lead to blindness. The company is now facing product liability lawsuits related to the case.

The FDA’s letter followed an inspection of the company’s plant, and said that while it did not find any conditions that may have contributed to or caused the infection, it did find “numerous other manufacturing problems” that are systemic and related to all products manufactured in the facility.

Some of the problems identified include:

• Failure to establish and maintain procedures that ensure a device’s design include a way to address incomplete, unclear or conflicting requirements
• Failure to establish and maintain procedures to prevent the contamination of equipment or products that may have an unfavorable effect on product quality
• Failure to establish and maintain procedures to efficiently control environmental conditions, such as temperature conditions
• Failure to ensure that all equipment used in the plant to manufacture products meets specifications
• Failure to document maintenance activities
• Failure to review, evaluate and investigate complaints involving the possible failure of a device labeling or packaging, including complaints relating to the ReNu with MoistureLoc Multi-Purpose solution that is believed to be linked to the eye infection

There have been 164 confirmed cases of Fusarium infections in 33 states and one US territory. 60 percent of the cases involved a patient reportedly using ReNu with MoistureLoc.

The FDA gave Bausch & Lomb 15 days to submit a plan for correcting the violations. Also in the warning letter, the FDA said it found no evidence of clinical problems relating to any other Bausch & Lomb products.

Sources: US Food and Drug Administration Warning Letter, October 31, 2006; Patricia Kowsmann, “FDA warns Bausch & Lomb on lens-solution infections,” Wall Street Journal, November 7, 2006; Ben Rand, “Bausch & Lomb gets warning from FDA on plant,” Rochester Democrat and Chronicle, November 7, 2006.

Bausch & Lomb’s ReNu with MoistureLoc lens cleaning solution was the only contact lens solution that was a contributing factor in the outbreak of fungal eye infections in the U.S. since June of 2005, according to the team of federal disease control experts and leading eye doctors analyzing adverse event reports on behalf of the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. Their report, published in today’s edition of the Journal of the American Medical Association (JAMA), challenges Bausch & Lomb’s assertion that it was customers’ failure to properly clean and store their contact lenses that contributed to their infections rather than a defect in the product itself.

It is still not clear exactly how ReNu with MoistureLoc contributes to Fusarium keratitis, the rare fungal infection that was confirmed in the 164 cases analyzed by researchers. Previously, Fusarium keratitis was only rarely seen among some rural agricultural workers who might have received a scratch in their eye from a plant that contained the fungus. Previous research reports found that the majority of users reported using ReNu with MoistureLoc to clean and care for their contact lenses prior to contracting Fusarium keratitis. Just over one-third of the total survey of 164 patients suffering from Fusarium keratitis in the U.S. required corneal transplants to recover from the damage to their eyes.

The reports authors concluded that there was still not enough evidence to identify the exact problem with Bausch & Lomb’s product, and that more research is needed. Dr. Todd P. Margolis of the Proctor Foundation for Ophthalmology Research at the University of California in San Francisco co-authored the commentary that accompanied today’s JAMA report. Dr. Margolis stated that cases of Fusarium keratitis may have started to rise before ReNu with MoistureLoc was first marketed. “There are many cases out there that haven’t been fully investigated,” Dr. Margolis said. While adverse event reports concerning Fusarium keratitis have slowed down considerably, healthcare experts continue to hear reports of infections that appear to be related to ReNu with MoistureLoc.

Bausch & Lomb recalled ReNu with MoistureLoc in the U.S. on May 15, 2006, after removing the product from some Asian markets as early as February. The company eventually concluded that the product formulation might allow Fusarium to colonize a lens case or bottle cap, especially if a consumer tops off his existing solution in a contact lens case instead of completely replacing it. Researchers found that while there was some evidence that topping off solution may raise a person’s risk of infection, there appeared to be no difference between the practices of the people who were infected and those contact lens wearers who remained healthy.

“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 wrote in an e-mail interview according to the New York Times. Dr. Chang is a CDC fungal disease specialist and lead author of the report. “However, the most important message for contact lens wearers is to stop using MoistureLoc.”

Sources: Barnaby J. Feder, “Lens Solution Caused Eye Infections, Report Says,” New York Times, August 22, 2006, accessed August 23, 2006; Douglas C. Chang, MD, et. al, “Multistate Outbreak of Fusarium Keratitis Associated With Use of a Contact Lens Solution,” Journal of the American Medical Association 296:8 (August 23-30, 2006).

While Bausch & Lomb’s ReNu with MoistureLoc product has been recalled, the danger to contact lens wearers may not be over. Research has shown that multipurpose contact lens solutions may cause surface damage to the eyes of contact lens wearers who use certain brands of contact lenses, damage that could make them more susceptible to infection. The phenomenon, known as ”corneal staining,” can harm the cornea itself by breaking the primary barrier of defense inside the eye.

The problem has been linked to the newest generation of contact lenses, silicone-hydrogel lenses, whose chemical properties may make them prone to absorbing the disinfectants in some brands of multipurpose lenses. Gas-permeable lenses may not interact as much with cleaning solutions, presenting a lower infection risk than silicone-hydrogel lenses.

Corneal staining, according to Dr. Kenneth Lebow, “indicates a break in the integrity of the cornea. Once we have a break in the primary barrier of defense, the potential increases for corneal infection.” Dr. Lebow is a Virginia optometrist who has done research for Alcon, Novartis and Bausch & Lomb.

Optometrist Gary Andrasko of Columbus, OH performed tests on more than 400 wearers of five different types of contact lenses. The tests measured the levels of corneal staining among the lens wearers when cleaned with seven multipurpose solutions. Most subjects showed some minor levels of corneal staining with all the brands of solution , but two brands performed especially poorly. Advanced Medical Options’ Complete MoisturePLUS solution produced high levels of staining, especially with Bausch & Lomb’s PureVision contact lenses. AMO has since recommended to doctors that the company’s product not be used with PureVision lenses.

Bausch & Lomb’s ReNu MultiPlus product performed worst of all, affecting an average of 73 percent of all subject’s corneal surface area with staining, even when used with the company’s own PureVision lenses. Bausch & Lomb has stated that in its own trials, PureVision lenses used with ReNu MultiPlus caused only minor levels of corneal staining.

An informal study by Christine Sindt, assistant professor of clinical ophthalmology at the University of Iowa, found ReNu with MoistureLoc cleaning solution produced what she called “dramatic” corneal staining in contact lens wearers. She reported her findings to Bausch & Lomb’s then director of professional relations, Fred Edmunds. According to Dr. Sindt, Mr. Edmunds told her that her the result from her study “wasn’t a big deal.”

Source: Sylvia Pagan Westphal, “Bausch & Lomb Solution Recall Exposes Risks for Eye Infections,” Wall Street Journal, July 26, 2006.

According to a Wall Street Journal report, the recent global outbreak of Fusarium keratitis infections in contact lens wearers that has been overwhelmingly traced to multipurpose contact lens solutions, especially the Bausch & Lomb product ReNu with MoistureLoc, is not necessarily news to eye care industry researchers. As early as 1999, published studies found that multipurpose contact lens solutions like ReNu with MoistureLoc may be less likely to kill dangerous organisms like Fusarium.

Bausch & Lomb products were often found to be more likely to grow bacteria in laboratory experiments of multipurpose solutions, and the company apparently didn’t like those results. Bausch & Lomb, a major player in the more than $6 billion annual contact lens and lens-care market, earned an estimated $2.23 billion last year, 23% of which came from the sale of contact lens-care products like ReNu MoistureLoc. But when news that ReNu solution was linked to fungal keratitis infections leading to corneal transplantation and scarring in patients in Singapore and the U.S., the company’s publicly-traded stock plunged from $60 per share to $47.91 at close of business on July 25, 2006.

The following studies were all published prior to Bausch & Lomb’s global recall of ReNu with MoistureLoc multipurpose contact lens cleaning solution:

• A study published in a 2000 edition of Contact Lens Spectrum found that among five popular contact-lens solutions which had Pseudomonas aeruginosa, a bacterial organism that causes common eye infections, added to samples, ReNu MultiPlusdid not kill the organism as well as other brands. Bausch & Lomb argued that their own internal study found ReNu to be just as effective as other brands and demanded an “immediate retraction” of the article by Indiana State University microbiologist Kathleen Dannelly. The university stood by its researcher and refused to retract Dr. Dannelly’s results.

• Studies by Alcon Inc. published in Contact Lens and Anterior Eye found multipurpose solution brands under conditions that simulated regular use by contact lens wearers, such as skipping rinsing and rubbing steps before leaving lenses to soak overnight, made multipurpose solutions less able to kill test organisms, including Fusarium.

• In 2003, University of Texas Southwestern researchers found that multipurpose solutions increase the binding of bacteria cells to the cornea, which they determined could potentially contribute to the increased risk of eye infections in contact lens wearers.

• In 2005 New York optometrist Arthur Epstein found that several cases of contact lenses left soaking in ReNu with MoistureLoc for a week became covered with what appeared to be a fungus. Although this was an informal experiment, Dr. Epstein, who is a spokesperson for the American Optometric Association, has said he has repeatedly been able to grow Fusarium and other microbes in lenses soaked for days in ReNu MoistureLoc solution. Although Dr. Epstein claims to have alerted Bausch & Lomb to his findings, Bausch & Lomb said it did not receive access to his methodology and cannot comment on unknown data. Bausch & Lomb claims its own investigation into the Fusarium outbreak, in which it added Fusarium to lenses soaked in ReNu MoistureLoc solution, did not cause the fungus to grow on lenses.

While incidences of Fusarium keratitis are still relatively rare - about 5 cases per 10,000 users - an estimated 60,000 people among that more than 125 million contact lens wearers worldwide could develop an infection each year from using multipurpose lens cleaning solution. At the present time, the Centers for Disease Control in the U.S. have concluded that there has been no statistically significant infection link to any other brand of multipurpose lens cleaning solution other than those manufactured by Bausch & Lomb.

Source: Sylvia Pagan Westphal, “Bausch & Lomb Solution Recall Exposes Risks for Eye Infections,” Wall Street Journal, July 26, 2006.

Physicians at the Singapore Eye Research Institute released a report today of their review of cases of Fusarium keratitis infection in Singapore. Fusarium keratitis is a rare fungal eye infection that is very rarely seen with contact lens wear but has been associated with soft contact lens wear in Asia and the United States. After a large percentage of soft contact lens wearers who contracted the infection reported using a cleaning solution manufactured by Bausch & Lomb called ReNu with MoistureLoc, the company recalled all lots of that product worldwide.

Wei-Boon Khor, M.B.B.S., and colleagues at the Singapore Eye Research Institute examined all cases of microbial keratitis reported in Singapore between March 2005 and May 2006 by collecting corneal samples from injury victims as well as their contact lenses and cases and their current bottles of contact lens solution. Researchers also conducted phone interviews with patients. Of the 66 contact lens wearers who contracted Fusarium keratitis, 93.9% of them used ReNu brand cleaning solution, including 63.6% who used ReNu MoistureLoc.

Two-thirds of the patients who contracted Fusarium keratitis developed severe, sight-threatening lesions requiring first-visit hospital stays that averaged six and one-half days. Some patients only recovered their visual acuity to 20/80 after infection, and five of the patients required corneal transplantation as a result of being infected with Fusarium keratitis.

Bausch & Lomb has said that its product is safe, but that improper usage of the product could render it sterile and therefore useless against infection. The authors did find that a great many contact lens wearers, 81.8%, practiced poor contact lens hygiene, including wearing their contacts while swimming, wearing expired contacts, or wearing daily contacts overnight. However, the authors suggested that these habits could not fully account for the outbreak in Singapore, and concluded that “Singapore is facing a new and unprecedented outbreak of Fusarium keratitis.” They encouraged eye care professionals around the world to “maintain a high index of suspicion for fungal infection when evaluating and treating patients with contact lens-associated microbial keratitis.”

Sources: Jon Kamp, “Contact-Lens Hygiene Problems,” Wall Street Journal, June 28, 2006; “Study documents outbreak of fungal eye infections among contact lens wearers in Singapore,” Brightsurf.com News, June 28, 2006; Wei-Boon Khor, MBBS, et. al, “An Outbreak of Fusarium Keratitis Associated with Contact Lens Wear in Singapore,” Journal of the American Medical Association 295: 24 (abstract), June 28, 2006.

Rochelle Feld has become the lead plaintiff in a class action personal injury lawsuit filed against Bausch & Lomb, makers of ReNu MoistureLoc contact lens solution. The suit alleges Bausch & Lomb is responsible for Ms. Feld’s injuries. Ms. Feld suffered cornea damage and was afflicted with Fusarium keratitis, a rare fungal eye infection, after using ReNu with MoistureLoc contact lens solution in October of 2005.

A spokesperson for Bausch & Lomb said the company will evaluate personal injury lawsuits on a “case by case basis.” Bausch & Lomb recalled ReNu with MoistureLoc after the FDA and Centers for Disease Control and Prevention confirmed at least 75 cases of Fusarium keratitis infection as being tied to their ReNu product.

Source: Sean Gardiner, “Coral Springs woman leads class-action suit against Bausch & Lomb,” South Florida Sun-Sentinel, June 8, 2006.

A New York Times report has raised troubling questions about the actions of Bausch & Lomb in personal injury cases of Fusarium keratitis, a fungal eye infection linked to its ReNu MoistureLoc (sometimes misspelled as MoistureLock) product. The report indicates that Bausch & Lomb received an alert from Dr. David Chu of New Jersey, a specialist in diseases of the cornea, on March 3, 2006. Dr. Chu was informing Bausch & Lomb that three of his recent patients had been infected with Fusarium, a microbial fungus that causes a potentially blinding eye infection.

According to the New York Times, Bausch & Lomb “quickly confirmed” that Dr. Chu’s infected patients has used their product, but did not report the adverse events to the U.S. Food and Drug Administration (FDA) or to the Centers for Disease Control (CDC). Bausch & Lomb had earlier agreed to stop selling ReNu MoistureLoc contact lens cleaner in Hong Kong and Singapore, but did not alert the CDC or the FDA that its product, manufactured in the U.S., was a potential cause of Fusarium infection overseas.

The company has released promotional videos on its website explaining its recall of ReNu MoistureLoc and assuring customers that they can trust its alternative product, ReNu MultiPlus solution, a product that has been on the market for some time. However, ReNu MultiPlus has also been linked to the fungal infection Fusarium keratitis. 19 confirmed cases of Fusarium keratitis have been traced to ReNu MultiPlus solution, manufactured at the same Greenville, SC, plant where ReNu MoistureLoc was produced. Customers who visit Bausch & Lomb’s website to hear CEO Ron Zarella speak about customer safety being his company’s “number one priority” are being encouraged to buy a product that has been linked to a full 20% of the cases under investigation in the U.S.

As of Friday, May 19, the CDC has confirmed 122 cases of Fusarium keratitis in the U.S., as well as 15 additional cases they consider “possible” Fusarium keratitis infections. There are 60 cases still under investigation in 33 U.S. states. 12 personal injury lawsuits alleging liability on the part of Bausch & Lomb in personal injury cases of Fusarium keratitis have been filed, including one in Pittsburgh, PA, in which a college student required cornea transplant surgery after being infected. Some plaintiffs’ attorneys are predicting there may be as many as 1,500 possible personal injury cases nationwide.

“I want to see more evidence,” said John Bullock, a former ophthalmologist and current epidemiologist at Wright State University, “but if a patient asked me now whether to use MultiPlus, I’d say throw it away.”

Source: Barnaby J. Feder, “From Asia to America, How Bausch’s Crisis Grew,” New York Times, May 18, 2006, accessed May 19, 2006; “Eye Patient Sues Bausch & Lomb over recalled lens solution,” ThePittsburghChannel.com, May 18, 2006, accessed May 19, 2006.

For more information:

New York Times Timeline: Tracking an Outbreak

The U.S. Food and Drug Administration (FDA) released a preliminary statement on the inspection it has conducted related to reports of microbial keratitis infection from Fusarium bacteria in contact lens wearers who have used Bausch & Lomb ReNu MoistureLoc contact lens cleaning solution. Among the most serious findings in the report was the fact Bausch & Lomb did not report to the FDA or the Centers for Disease Control (CDC) that 35 cases of Fusarium keratitis in Singapore were confirmed as being linked to their product within 35 days as required for products manufactured in the United States. The company had reports of problems as early as July 2005 but had not reported details to the FDA as of May 9, 2006.

To date, the FDA and the CDC have confirmed 122 cases of Fusarium keratitis in the U.S., with a disproportionate number of cases linked to a Bausch & Lomb manufacturing facility in Greenville, SC. Bausch & Lomb “was asleep at the switch with this one,” said Ira Loss in the Los Angeles Times. Loss is a research analyst with Washington Analysis, an investment firm that advises institutional investors. Loss has been monitoring the FDA for more than 20 years. “This is classic poor management in the oversight of manufacturing.”

According the FDA’s preliminary report, eye infections in contact lens wearers who used ReNu MoistureLoc may be related to the product’s design and how consumers use it. Now that the FDA has issued a preliminary report, their next step will be to review a more detailed report by agency inspectors and then determine its next enforcement step, which could include meeting with Bausch & Lomb management, issuing a warning letter or seizing products. In most cases, if companies voluntarily correct manufacturing problems after an FDA warning letter, the agency will take no further action. Consumers who have been harmed by the product must pursue remedies through the legal system, where the courts will determine whether the company is liable for damages.

Microbial keratitis is a rare but potentially serious infection of the cornea that can lead to vision loss. Fusarium keratitis , also called fungal keratitis, is caused by the Fusarium bacteria, normally found in soil, water and other types of organic matter which can get transferred to the eye area under rare conditions. When this fungus infects the eye, it becomes extremely hard to treat. Fusarium keratitis sufferers must undergo treatment for up to three months.

Fusarium infections cause inflammation of the cornea. Symptoms include blurry vision, discharge, swelling, pain and increased sensitivity to light. In severe cases, Fusarium infections can lead to corneal scarring and permanent blindness.

The FDA observed 20 potential safety violations in its report of the Greenville facility inspection, including:

• Failure to notify the FDA in writing about the removal of the ReNu MoistureLoc product from the Singapore and Hong Kong markets in February, 2006 due to its concern about FFusarium keratitis contamination
• Failure to follow proper procedures to prevent contamination of equipment
• Lack of procedures for storing products in storage areas and stock rooms that would prevent the mixture of products
• Lack of proper temperature monitoring in a storage warehouse and other areas where product was kept for long periods of time

An estimated 2.3 million of the 30 million Americans who wear contact lenses are believed to use the ReNu MoistureLoc product.

Sources: “Bausch delayed case reports, FDA says,” Bloomberg News, May 17, 2006; Abdul-Salaam Masheer, “FDA says Bausch & Lomb failed to report eye infections,” Earthtimes.org, May 17, 2006; “Alert over contact lens solution,” BBC News, May 17, 2006; “FDA: Bausch & Lomb didn’t disclose cases,” Associated Press,” May 16, 2006, accessed May 17, 2006; FDA Statement on Preliminary Bausch & Lomb Inspection Findings, May 16, 2006, accessed May 17, 2006.

The U.S. Food and Drug Administration (FDA) released a preliminary statement on the inspection it has conducted related to reports of microbial keratitis infection from Fusarium bacteria in contact lens wearers who have used Bausch & Lomb ReNu MoistureLoc contact lens cleaning solution. Among the most serious findings in the report was the fact Bausch & Lomb did not report to the FDA or the Centers for Disease Control (CDC) that 35 cases of Fusarium keratitis in Singapore were confirmed as being linked to their product within 35 days as required for products manufactured in the United States. The company had reports of problems as early as July 2005 but had not reported details to the FDA as of May 9, 2006.

To date, the FDA and the CDC have confirmed 122 cases of Fusarium keratitis in the U.S., with a disproportionate number of cases linked to a Bausch & Lomb manufacturing facility in Greenville, SC. Bausch & Lomb “was asleep at the switch with this one,” said Ira Loss in the Los Angeles Times. Loss is a research analyst with Washington Analysis, an investment firm that advises institutional investors. Loss has been monitoring the FDA for more than 20 years. “This is classic poor management in the oversight of manufacturing.”

According the FDA’s preliminary report, eye infections in contact lens wearers who used ReNu MoistureLoc may be related to the product’s design and how consumers use it. Now that the FDA has issued a preliminary report, their next step will be to review a more detailed report by agency inspectors and then determine its next enforcement step, which could include meeting with Bausch & Lomb management, issuing a warning letter or seizing products. In most cases, if companies voluntarily correct manufacturing problems after an FDA warning letter, the agency will take no further action. Consumers who have been harmed by the product must pursue remedies through the legal system, where the courts will determine whether the company is liable for damages.

Microbial keratitis is a rare but potentially serious infection of the cornea that can lead to vision loss. Fusarium keratitis, also called fungal keratitis, is caused by the Fusarium bacteria, normally found in soil, water and other types of organic matter which can get transferred to the eye area under rare conditions. When this fungus infects the eye, it becomes extremely hard to treat. Fusarium keratitis sufferers must undergo treatment for up to three months.

Fusarium infections cause inflammation of the cornea. Symptoms include blurry vision, discharge, swelling, pain and increased sensitivity to light. In severe cases, Fusarium infections can lead to corneal scarring and permanent blindness.

The FDA observed 20 potential safety violations in its report of the Greenville facility inspection, including:

• Failure to notify the FDA in writing about the removal of the ReNu MoistureLoc product from the Singapore and Hong Kong markets in February, 2006 due to its concern about Fusarium keratitis contamination
• Failure to follow proper procedures to prevent contamination of equipment
• Lack of procedures for storing products in storage areas and stock rooms that would prevent the mixture of products
• Lack of proper temperature monitoring in a storage warehouse and other areas where product was kept for long periods of time

An estimated 2.3 million of the 30 million Americans who wear contact lenses are believed to use the ReNu MoistureLoc product.

Sources: “Bausch delayed case reports, FDA says,” Bloomberg News, May 17, 2006; Abdul-Salaam Masheer, “FDA says Bausch & Lomb failed to report eye infections,” Earthtimes.org, May 17, 2006; “Alert over contact lens solution,” BBC News, May 17, 2006; “FDA: Bausch & Lomb didn’t disclose cases,” Associated Press,” May 16, 2006, accessed May 17, 2006; FDA Statement on Preliminary Bausch & Lomb Inspection Findings, May 16, 2006, accessed May 17, 2006.

The U.S. Food and Drug Administration (FDA) released a statement on Monday, May 15, 2006 announcing that Bausch & Lomb, makers of the ReNu MoistureLoc contact lens cleaning solution product that has been linked to at least 32 confirmed cases of Fusarium keratitis infection in the United States, has recalled the product worldwide.

ReNu MoistureLoc contact lens solution, manufactured in a Bausch & Lomb plant located in Greenville, SC, was voluntarily withdrawn from the U.S, market on April 13 after FDA and Centers for Disease Control (CDC) investigations determined that the majority of confirmed cases under investigation since March 22, 2006 appeared to have originated from that facility. The FDA and CDC investigations of the Greenville plant are still being finalized and a report has not yet been released; however Bausch & Lomb says the now decided to permanently remove the product worldwide.

The FDA reported that a team from Bausch & Lomb met with the agency on May 11 to share the results of their internal investigation into possible Fusarium keratitis contamination of their product. According to the FDA, Bausch & Lomb believes “unique characteristics of the formulation of the