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Bausch & Lomb's solution infected eyes, CDC says

By ALISON YOUNG
The Atlanta Journal-Constitution

Published on: 08/23/06

A Bausch & Lomb contact lens solution – not poor consumer hygiene — was the major factor in an outbreak of severe eye infections, according to a final report by investigators at the Centers for Disease Control and Prevention.

The outbreak, which began last summer, involved 164 confirmed U.S. cases of fusarium keratitis, a rare eye infection caused by fusarium fungus. Of those patients, 55 needed corneal transplants to save their sight, according to the report, published today in the Journal of the American Medical Association.

ReNu with MoistureLoc, a popular contact lens solution permanently removed from the worldwide market by Bausch & Lomb in May, was the only solution linked to the outbreak, the investigation found. It had been used by 2.3 million U.S. contact lens wearers.

Initial information that another Bausch & Lomb solution, ReNu MultiPlus, may also have played a role was likely the result of consumer confusion about the two similarly packaged products, the report said.

It appears the outbreak may have been caused by interaction between the unique chemistry of the MoistureLoc solution, fusarium fungus already in the consumers' homes and possibly the lens case or the contact lens, the CDC researchers said, noting that the question needs further study. Fusarium fungus is commonly found in soil, plant material and in wet environments, primarily in warm climates.

MoistureLoc relied on a disinfectant, alexidine, and a special moisture-retaining chemical that are not used in any other soft contact solutions currently on the market, the study found. While the formula was effective against fusarium in lab tests, it wasn't in real-life use.

"We really don't think the outbreak was caused by any breakdown in hygiene measures," said Dr. Benjamin Park, a CDC medical officer and co-author of the study, which examined outbreak cases and a control group of uninfected contact lens wearers. "Hygiene was poor in both groups."

Much to the dismay of eye care professionals, contact lens wearers commonly care for their lenses in a sloppy and risky manner: handling lenses with unwashed hands, rarely or never cleaning and replacing their cases, leaving caps off solution bottles and sleeping in their lenses. And while lax lens care was universal among those who were studied, CDC investigators found outbreak victims more frequently engaged in the bad practice of reusing the solution already in their lens cases to store their contacts.

Bausch & Lomb officials said the CDC report, along with other recent studies, document the widespread failure of contact lens wearers to follow recommended lens care practices.

"Reusing solution in the lens case can reduce the effectiveness of any product and increases the risk of infection of any kind," said Meg Graham, a company spokeswoman, in a written statement.

"We think the report confirms that Bausch & Lomb took the right action in the interest of consumer health and safety by recalling the MoistureLoc product, and that Bausch & Lomb can continue to recommend its ReNu MultiPlus solution with confidence," she said.

While CDC officials are confident the fusarium outbreak is over, Park said a few infection reports have continued to trickle in, despite the MoistureLoc recall and Bausch & Lomb's ads last spring urging consumers to stop using the product.

"We're concerned the message hasn't gotten out to people to stop using MoistureLoc," he said.

Dr. Doyle Stulting, a professor of ophthalmology at Emory University, said his practice has treated about 10 cases of fusarium eye infections since news of the outbreak surfaced earlier this year. Most have completed treatments with anti-fungal medications and are doing well, he said.

But 16-year-old Milinda Mitchell of Stone Mountain said she is still battling infections — more than four months after she was first diagnosed at Emory Eye Center. At one appointment the infection will seem to be getting better, she said, then at the next a new scar will be on her cornea.

"It's devastating," said Milinda, a Clarkston High School junior who had been a MoistureLoc user. "I have three scars, two on my left eye and one on my right." Most of the time, the scars are outside her line of sight. But when they're not, "it looks like a little fluffy white spot," she said.

The repeated trips to the doctor, missed school for Milinda and missed work for her mother, expensive prescription eye drops and the lingering threat to her eyesight are things they never anticipated when Milinda started wearing contacts three years ago.

"I told her she's not wearing contacts anymore," said Danala Thomas, Milinda's mother