Fungal Eye Infections,
Including Updates About
ReNu With MoistureLoc

By AllAboutVision.com Staff
Page last updated June 12, 2009

To help prevent potentially blinding fungal and other eye infections, stricter labeling and testing requirements for contact lens solutions were recommended at FDA hearings conducted last year to address ongoing safety concerns for contact lens wearers.

Researchers say organisms resistant to treatment appear to have caused serious fungal keratitis eye infections linked to Bausch & Lomb's recalled contact lens solution, ReNu With MoistureLoc.

In June 2009, news reports indicated that Bausch & Lomb settled about 600 lawsuits related to the contact lens solution by paying approximately $250 million in claims.

University Hospitals Case Medical Center researchers at Cleveland previously said glue-like "biofilms" within the solution where contact lenses were stored allowed organisms such as Fusariam fungus to thrive. Beyond thriving, organisms living within biofilms also became resistant to disinfecting properties of the contact lens solution.

"One of the underlying reasons for ReNu With MoistureLoc not being effective against the outbreak of keratitis is that the solution is not effective against biofilms and the organisms contained in biofilms," said Mahmoud A. Ghannoum, PhD, director of the Center for Medical Mycology.

From 2005 to 2006, Bausch & Lomb's ReNu with MoistureLoc contact lens solution became increasingly associated with outbreaks of fungal keratitis. In May 2006, the company voluntarily withdrew the product from worldwide markets.

In another incident, Advanced Medical Optics (AMO) announced in late May 2007 that the company was withdrawing its Complete MoisturePlus contact lens solutions from the marketplace because of a possible association with development of eye infections known as Acanthamoeba keratitis.

In a 2008 announcement of research findings, Ghannoum noted that manufacturers of contact lens solutions have been conducting tests of disinfecting properties by using a type of fungus that does not produce biofilms, which often contaminate contact lens cases. He recommended that testing procedures for multipurpose contact lens solutions be expanded to specifically address effectiveness in the presence of biofilms.

Contact lens wearers also should be vigilant in making sure lenses and cases are cleaned and handled properly, Ghannoum said.

Background of Link Between Fungal Eye Infections and Contact Lens Solutions

In late 2006, the FDA issued a warning letter saying Bausch & Lomb had inappropriately delayed reporting fungal eye infections associated with its ReNu With MoistureLoc contact lens solution, which now has been permanently withdrawn from U.S. and global markets.

The FDA letter provided details about manufacturing and quality control issues found during inspections conducted from March through May 2006 at Bausch & Lomb's Greenville, S.C. plant. However, investigations showed that it was the formulation of ReNu With MoistureLoc rather than manufacturing processes that likely contributed to the outbreak of fungal keratitis eye infections among contact lens wearers.

In early 2006, soft contact lens wearers were warned about a possible link between use of the once popular contact lens cleaning/disinfectant solution ReNu With MoistureLoc and development of a potentially serious fungal keratitis eye infection that can damage the eye's surface (cornea).

In mid May of that year, Bausch & Lomb voluntarily withdrew ReNu With MoistureLoc products worldwide while investigations continued.

Evidence began to show an association between the specific formula in ReNu With MoistureLoc and development of a film within contact lens cases that blocked disinfectant properties needed to destroy the fungus (Fusarium) causing the eye infections.

More About Outbreaks of Fungal Eye Infections

A U.S. Centers for Disease Control (CDC) study of the fungal eye infection outbreak, reported in the Aug. 23-30, 2006 issue of the Journal of the American Medical Association (JAMA), found that:

U.S. Centers for Disease Control (CDC) technician Shirley McClinton displays Fusarium mold grown from a contaminated pair of contact lenses, still visible in this Petri dish. (Photo by James Gathany, CDC.)

• In 33 U.S. states and Puerto Rico, 164 cases of fungal keratitis eye infections were confirmed between June 1, 2005 and June 30, 2006.
• 94 percent of these cases were among soft contact lens wearers.
• In about 34 percent of those cases, corneal transplants were needed.
• Individuals who developed fungal keratitis eye infections were 20 times more likely to have used the Bausch & Lomb ReNu With MoistureLoc formula than a control group. (See more details below.)

In response to findings related to ReNu With MoistureLoc, Bausch & Lomb in an Aug. 22, 2006 statement noted that earlier investigations also revealed widespread non-compliance with recommended care and cleaning of contact lenses and cases among people who were infected.

"As always, we remain committed to continuing to provide health professionals and contact lens wearers with information about the importance of following proper lens care and wear regimens to ensure safe and healthy contact lens wear," company officials said in the statement.

In the August 2006 JAMA article, study authors said exposure to the fungus appeared to occur outside manufacturing processes involving the contact lens solution. But authors noted that "suboptimal contact lens hygiene practices appear unlikely as the major explanation for the outbreak."

Bausch & Lomb company officials disputed FDA findings saying the company delayed reporting possible problems related to the contact lens solution that were evident as early as July 2005. The FDA report and warning letter issued in October 2006 also said Bausch & Lomb failed to immediately report information about 35 fungal keratitis eye infection cases provided in February 2006 from the Singapore Ministry of Health.

Bausch & Lomb officials said the July 2005 incidents did not appear to specifically involve fungal keratitis eye infections, and that the company did report the Singapore information in an April 5, 2006 briefing with FDA officials.

In a 2007 report to the U.S. Securities and Exchange Commission (SEC), Bausch & Lomb noted one federal class action lawsuit and 550 individual legal actions had been filed against the company that alleged personal injury from use of Renu With MoistureLoc contact lens solution.

Fungal Eye Infection Statistics

Other conclusions from the CDC study:

• Fusarium fungal eye infections were not associated with manufacturing processes. CDC investigators said they found no fungal contamination in areas such as the ReNu With MoistureLoc factory, warehouse, or unopened solution bottles.
• Only Bausch & Lomb ReNu With MoistureLoc was implicated in the outbreak. No other Bausch & Lomb contact lens solutions, including ReNu MultiPlus, or similar products from other companies appeared involved in the outbreak. Only Bausch & Lomb ReNu With MoistureLoc was implicated.
• Exposure to the fungus occurred outside manufacturing facilities, possibly in some cases within homes of contact wearers. While unsanitary practices were not considered the main reason for the outbreak, exposure to the fungus likely occurred in places such as within the homes of contact lens wearers. The CDC urges contact lens wearers to practice safety in storage, care, and handling of contact lenses and cases. (See tips below.)

Fungal Eye Infection Symptoms

The source of the 2005-2006 outbreak of fungal eye infections is a fungus known as Fusarium, found in places such as soil, water, and organic matter including plants. Ordinarily, it is rare for this fungus to invade and damage the eye. But when this type of fungal eye infection does occur, it can be very difficult to treat. Some individuals with extensive eye damage might even require a corneal transplant. Early diagnosis and treatment of these types of fungal eye infections can significantly reduce the possibility of serious eye damage, according to the June 2006 issue of Archives of Ophthalmology.

If you suspect you have a fungal eye infection, see your eye doctor immediately. Symptoms of fungal keratitis eye infection can include:

• Eye lesions.
• Clouding of the eye's surface.
• Significant eye inflammation.
• Blurring and vision loss.
• Eye irritation, discharge, swelling, pain, tearing, and/or redness.
• Light sensitivity (photophobia).

Overview of 2006 Fungal Eye Infection Outbreak

First Outbreak in Asia: In February 2006, clustered outbreaks of fungal keratitis eye infections were reported among contact lens wearers in Singapore and Hong Kong, where investigators identified an association with Bausch & Lomb ReNu With MoistureLoc contact lens cleaning solution. Malaysia also has reported outbreaks associated with the contact lens solution. These unusual numbers of Asian cases reportedly were first noticed beginning in the fall of 2005.

U.S. Outbreak: In early 2006, increasing numbers of fungal eye infections primarily among contact lens wearers also began showing up in the United States. These infections were largely associated with the same contact lens cleaning/disinfectant solution. As of June 2006, the CDC had reported 164 confirmed cases of fungal keratitis eye infections dating from June 1, 2005 in 33 states and Puerto Rico.

European Outbreak: In early May 2006, news reports indicated that a few fungal keratitis eye infections were being investigated in Europe to determine any possible link to use of contact lens solutions. Italian health inspectors reportedly were inspecting a Bausch & Lomb plant in Milan where the ReNu With MoistureLoc contact lens solution is made.

How To Prevent Fungal Eye Infections

• Do not use any ReNu With MoistureLoc contact lens solution you might have on hand. Make sure you discard this product. Ask your eye doctor what solution to use instead. (Remember, not every solution is compatible with every contact lens.)
• Use good hygiene, which includes hand-washing before handling contact lenses.
• Make sure contact lens cases are cleaned and stored in a sanitary way. Replace your contact lens storage case routinely, as recommended by your eye doctor.
• Contact Lenses Today (April 23, 2006) advised contact lens wearers never to "top off" old contact lens solution with new solution. Throw away the old solution completely, clean the contact lens case, and use fresh, new solution.
• The American Optometric Association and FDA now recommend rubbing and rinsing contact lenses, even when using a "no-rub" product.
• Wear contact lenses only according to schedules outlined by your eye doctor and contact lens manufacturer.

[For more information about safe handling and wear of contact lenses, read Caring for Soft Contact Lenses.]

[Page updated June 2009]