Cases of Fusarium keratitis associated with ReNu with MoistureLoc

Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in November 2005. See http://www.aoa.org/x5161.xml. In February 2006, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions both in Singapore and Hong Kong. On March 8, 2006, The Centers for Disease Control and Prevention (“CDC”) received a report from an ophthalmologist in New Jersey concerning a cluster of three patients with contact lens-associated Fusarium keratitis during the preceding 3 months. Source American Optometric Association. See http://www.aoa.org/x5159.xml.

As of April 9, 2006, a total of 109 patients with suspected Fusarium keratitis were under investigation in 17 different states in the United States. See http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55d410a1.htm. Prior to this problem, fungal keratitis had been rarely reported in the healthy soft contact lens wearing population. Historically, the vast majority of contact lens related microbial keratitis has been caused by bacterial pathogens such as Pseudomonas aeruginosa. See http://www.aoa.org/x5166.xml. The FDA News, P06-56 explained, “organisms associated with contact lens-related keratitis are usually bacteria rather than fungus, often arising from contamination of lens care products or from contact lens storage cases.”

Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, up to 35% of microbial keratitis cases are fungal keratitis, compared with 1% in New York. The proportion of fungal keratitis attributable to Fusarium spp. also varies by region, from 25% to 62%. First-line treatment includes topical and oral antifungal medications. Patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation. Fusarium keratitis is not transmitted from person to person. MMWR Dispatch. According to the MMWR Dispatch, complete data are available for 30 patients whose median age was 48 years (range: 13-83 years), and 21 (70%) were female; infection onset occurred between June 15, 2005 and March 18, 2006. Twenty-eight patients (93%) wore soft contact lenses and 26 of those reported using a Bausch & Lomb brand contact lens solution or a generic-brand solution manufactured by Bausch & Lomb. Patients reported using various ReNu product types from multiple product lots. It is believed that all of these cases stem from solution manufactured in Bausch & Lomb’s Greenville, South Carolina manufacturing plant.

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