Bausch pulls contact solution off market
Bausch withdraws MoistureLoc from market, citing links to fungal infections in contact wearersMay 15, 2006 | CNN
Bausch & Lomb said on Monday that it is removing from the market a brand of contact solution that has been linked to fungal infections in the eyes of its customers.
Bausch, based in Rochester, N.Y., said it is immediately and permanently removing ReNu MoistureLoc contact solution from stores around the world, and not just in markets where the infections have been reported.
"After an extensive investigation involving thousands of tests, millions of dollars and collaboration with government agencies, health authorities and independent experts, there is no evidence of product contamination, tampering, counterfeiting of sterility failure," said Bausch chief executive officer Ronald Zarrella, in a press release. "That leads us to conclude that some aspect of MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances."
Bausch's (up $1.66 to $46.10, Research) stock price has plunged 23 percent since reports of the fungal infections emerged in the beginning of May. But the removal could have a comparatively light impact on sales. Sales of MoistureLoc, introduced in late 2004, totaled $100 million in 2005 sales, the company said, a fraction of the $2.2 billion in revenue the company reported for 2004, in the latest tally available. Bausch has delayed filing of its 2005 annual report, partly as a result of questionable accounting practices with a Korean subsidiary.
Health officials in the Hong Kong, Singapore and United States have reported cases of a rare eye infection, fusarium keratitis, in patients who used MoistureLoc contact solution. Further complicating Bausch's situation, the company stopped selling the contact solution in the U.S. only in April, 2006, even though it had been informed of problems by the Hong Kong health authorities in November, 2005.
The Food and Drug Administration and the Centers for Disease Control have acknowledged that incidence of the rare infection is disproportionately high in MoistureLoc users, and the FDA has been investigating a company plant in Greenville, S.C.
"Bausch & Lomb has proposed that unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection," said the FDA on Monday. The FDA said it "supports" Bausch's decision to remove MoistureLoc from the market, but the company and the FDA said Bauch's other brands of contact solution are safe.
Fusarium keratitis is a rare but serious fungal infection of the cornea, according to the Academy of Ophthalmology. The infection causes blurry vision, redness and pain in the eye, excessive tearing or discharge from the eye, and increased sensitivity to light.