| Updates about ReNu and Fusarium keratitis |
| Thursday, 24 August 2006 | |
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Early this year, people who wear soft contact lenses learned about a likely link between use of the popular ReNu with MoistureLoc solution and the fungal infection Fusarium keratitis, which has been known to damage the cornea (surface of the eye).
In mid-May, Bausch & Lomb issued a complete ReNu recall. Evidence has shown that the formula in ReNu with MoistureLoc permits the development of a film within contact lens cases that had the unintended result of blocking the disinfectant properties that would prevent the fungus in the first place. And, according to the Lancet medical journal, the film that enhances wearer comfort helped create an environment in which the fungus thrived. A study by the Centers for Disease Control and Prevention determined that:
Bausch & Lomb again noted that earlier investigations revealed considerable non-compliance with recommended cleaning and care of contact lenses. But the authors of the CDC study disagreed, saying that “suboptimal contact lens hygiene practices appear unlikely as the major explanation for the outbreak.” * * * On May 17, Bausch & Lomb issued a news release that sought to refute findings by the Food and Drug Administration that the company had unnecessarily delayed reporting of ReNu fungus problems as early as July 2005. The FDA had cited Bausch & Lomb for failing to immediately pass along a report of 35 Fusarium keratitis infections given to it by the Singapore Ministry of Health. * * * The U.S. Securities and Exchange Commission reported that at least 19 different ReNu lawsuits (including 12 class action ReNu lawsuits) have been filed against the company. * * * According to the Journal of the American Medical Association, the Fusarium keratitis eye infections did not come from the manufacturing process. Only Bausch & Lomb’s ReNu with MoistureLoc was implicated in the outbreak; no other B&L contact lens solution, nor that of any other company, was involved. And finally, exposure to the fungus may have come in the homes of users. Although unsanitary practices were not blamed for the outbreak, users were urged to practice safety in storage, care and handling of their contact lenses and the cases in which they are held. * * * The 2005–2006 outbreak of eye infections came from a fungus known as Fusarium, which can be found in soil, water and various kinds of organic matter. The fungus does not ordinarily invade and damage the eye, but it is hard to treat when it does. Some people with extensive eye damage require corneal transplants. And, according to the Archives of Ophthalmology, early diagnosis and treatment is the key to minimizing the ReNu fungus. * * * These are some of the symptoms of Fusarium keratitis: eye lesions; clouding of the surface of the eye; inflammation of the eye; blurring and loss of vision; eye irritation, discharge, swelling, pain and tearing; and sensitivity to light. * * * Here is an overview of the ReNu fungal eye infection outbreak: In Fall 2005, there were reports of clustered outbreaks of Fusarium keratitis eye infections in Singapore, Hong Kong and Malaysia. Investigators there associated the cases with Bausch & Lomb’s ReNu with MoistureLoc contact lens solution. A few months later, in early 2006 the number of fungal eye infections among contact lens wearers in the United States began to climb—and they, too, tended to be linked to ReNu with MoistureLoc. By mid-summer, the CDC had confirmed 164 cases of Fusarium keratitis in 33 states and Puerto Rico. Bausch & Lomb confirmed that “a few” cases of Fusarium keratitis among users of its ReNu with MoistureLoc contact lens solution have been found in Europe. Those cases represent the company’s first acknowledgment of European incidents of the outbreak, which had previously been limited to Asia and the U.S. Italian health officials were reportedly inspecting a Bausch & Lomb plant in Milan where ReNu with MoistureLoc is made. Previous suspicions centered on the company’s plant in Greenville, South Carolina.
* * * Fungal eye infections such as Fusarium keratitis can be prevented by following a few simple steps, such as:
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