Contact lens maker pulls solution
Solution was pulled Monday due to eye fungus outbreaksMay 16, 2006 | OSU Daily Barometer A popular contact lens cleaning solution was pulled from retail shelves Monday in connection with a far-reaching outbreak of fungal eye infections known to cause blindness.
Bausch and Lomb’s ReNu with Moisture-Loc contact lens solution is currently under investigation by the Food and Drug Administration and the Center for Disease Control in conjunction with its ability to harbor fusarium, a fungus that is commonly found in organic matter such as soil and plants.
The company suspended U.S. sales of the product following a CDC investigation announced April 10.
Sales have been suspended in the Far East since Feb. 18, following outbreaks in Singapore, Hong Kong and Malaysia.
“Bausch & Lomb’s top priority is the safety of our customers, and we want them to have complete confidence in our products,” the eye-care product maker’s chief executive, Ronald Zarrella said in a press release.
Fusarium keratitis is a fungal infection of the eye that, if left untreated, can lead to scarring of the cornea and eventually blindness.
The CDC has reported that this infection cannot be transmitted from person to person. People who have trauma to the eye, certain eye diseases and problems with their immune system may be at increased risk for these types of infection.
The rise in infections has brought about a variety of lawsuits with many of its victims having to undergo corneal transplants. The probability of the host rejecting the transplanted eye is higher than 80 percent.
The CDC has confirmed 122 cases of fusarium keratitis in the U.S., with 15 possible cases and another 60 being investigated. Cases have been confirmed or are being investigated in 33 states.
More than half of the confirmed cases involved use of B&L’s ReNu with Moisture-Loc contact lens solution.
About a third of the cases involved any of the other ReNu products and less than 10 percent of the cases involved Advanced Medical Optics and Alcon products.
Around 30 million Americans wear contact lenses, with about 2.3 million of them using the ReNu with Moisture-Loc solution. Another 11 million use the MultiPlus solution. The Moisture-Loc solution, released in late 2004, contributed to roughly $45 million in global sales last year.
Some eye-care experts have theorized that Alexidine, the new disinfecting agent used in the Moisture-Loc solution, in conjunction with poor hygiene habits can lead to an outbreak of the infection.
In response to the rising concerns, the FDA has joined forces with the CDC and has been inspecting the Bausch & Lomb plant and facilities in Greenville, S.C. since March 22.
Extensive federal inspections of the factory where Moisture-Loc was made for U.S. and several Asian markets have not turned up evidence of “contamination, tampering, counterfeiting or sterility failure,” said Zarrella.
“This is a serious infection and soft contact lens users should be mindful of the potential to develop this problem,” said Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health.
Healthcare providers have been urged to stop using all ReNu products and to advise their patients to do the same.
Contact lens wearers are encouraged to consult their eye-care provider to find an alternative product and to employ the “rub and rinse” technique to clean their contacts rather than the no-rub method.
In the event of symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling with the use of contact lenses, contact your eye-care professional immediately.
Bausch & Lomb also makes contact lenses, ophthalmic drugs and vision-correction surgical instruments, generates more than $2 billion in annual revenues and employs 12,400 people.