CDC: B&L methods not to blame in infectionsAug 22, 2006 | www.democratandchronicle.com
Bausch & Lomb Inc.’s manufacturing methods were probably not to blame for the outbreak of a rare eye infection among contact lens wearers associated with the use of a popular B&L lens solution, public health investigators have concluded.
The Centers for Disease Control and Prevention have said in an article to be published tomorrow that it was “unlikely” that B&L’s ReNu with MoistureLoc solution came into contact with the fungus causing the infection during the production process.
Instead, the study to be published in the Journal of the American Medical Association, suggests that the outbreak of Fusarium keratitis, a sight-threatening infection, “may” have been caused by a complex and undetermined interaction between MoistureLoc, the Fusarium fungus and, possibly, the lens case or contact lens itself.
B&L said the CDC study “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 major conclusion of the study, according to its chief author, is to confirm that contact lens wearers should not use ReNu with MoistureLoc. B&L recalled the product worldwide in mid-May.
Investigators noted that MoistureLoc contains two ingredients not found in other soft contact lens solutions currently on the market, and that those unique properties “may have contributed” to fungal infection in certain instances.
The CDC’s results support both preliminary conclusions made by the Food and Drug Administration in May as well as the company’s own investigation. Executives told the Democrat and Chronicle in May that there was enough evidence to show that a polymer in the formula was an inadvertent culprit.
“This has been a very unique situation, a very unique outbreak,” said Dr. Douglas Chang, an officer with the epidemic intelligence service with the CDC.
The CDC said in its paper it had identified 164 cases of Fusarium by June 30. Those with the infection were statistically more likely than not to be users of MoistureLoc.