Contact Lenses
This article was originally published in RAJ Devices
Executive Summary
Link reported between fungal infection and contact lens solution
Link reported between fungal infection and contact lens solution
A study in the Journal of the American Medical Association has concluded that the recent increases of Fusarium keratitis among contact lens users were associated with Bausch & Lomb's contact lens solution, ReNu with MoistureLoc. Fusarium keratitis is a rare but serious fungal infection in the eye. The study, published on 23 August 2006, has recommended that contact lens wearers should not use the product.
The investigators, which included experts from the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, identified 164 confirmed cases of patients with Fusarium keratitis in 33 US states and one US territory as of 30 June 20061. In 34% of cases, the infection was so severe that the patient needed a corneal transplant in order to save his sight.
Douglas Chang and colleagues from the CDC conducted a case-control study in order to determine the specific activities, contact lens hygiene practices or products associated with the outbreak. One hundred and fifty-four, or 94%, of the confirmed cases wore soft contact lenses. Forty-five cases and 78 controls were included in the study which concluded that cases were more than 20 times more likely than controls to report using ReNu with MoistureLoc. The authors said that other products, including ReNu MultiPlus, were not associated with Fusarium keratitis.
“Our findings, together with the results of environmental testing, suggest that exposure to Fusarium was likely the result of extrinsic contamination of contact lens solution bottles or lens cases occurring outside of the manufacturing or storage processes, perhaps in patients' homes. However, suboptimal contact lens hygiene practices appear unlikely as the major explanation for the outbreak,” the researchers wrote.
Bausch & Lomb said that it “thinks the report confirms that [the company] 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”2.
Investigations began early this year when multiple reports of Fusarium keratitis were reported to the US Food and Drug Administration (FDA) and the CDC. Cases were also reported to authorities in Hong Kong and Singapore. The FDA centred investigations on ReNu with MoistureLoc and Bausch & Lomb withdrew the product worldwide on 15 May 20063. Studies are on-going to determine if the infections were caused by an interaction of the product's ingredients with Fusarium that might have permitted the growth of the organism, according to the study.
References
1. Report Issued on Serious Eye Infection Linked with use of Certain Contact Lens Solution, 22 August 2006, http://pubs.ama-assn.org/media/2006j/0822.dtl#report
2. Bausch & Lomb press release, 22 August 2006, www.bausch.com/en_US/corporate/corpcomm/news/082206_BL_Comments_on_Fusarium_Keratitis_Article.aspx
3. The Regulatory Affairs Journal - Devices, 2006, 14(3), 157