April 14, 2006

Consumers Advised to Not Use Bausch & Lomb Product as Fungal Keratitis Investigation Continues

As of April 13, Bausch & Lomb is advising consumers not to use its ReNu with MoistureLoc contact lens solution while investigations continue into the increase in reported cases of Fusarium keratitis. The company has also asked retailers to temporarily pull the product from shelves, which many stores were already doing.

The U.S. Centers for Disease Control and Prevention (CDC) has not reached any definitive conclusions yet about the source of the infections. Ophthalmologists from the Bascom Palmer Eye Institute at the University of Miami School of Medicine and the Wilmer Eye Institute at Johns Hopkins are working with the CDC and the U.S. Food and Drug Administration (FDA) on the investigation.

• Report additional cases of Fusarium keratitis or unusual infection patterns to MedWatch by phone at 800.FDA.1088, by fax at 800.FDA.0178 or online through the FDA's Web site.
• Consider fungal infection when evaluating patients with infectious keratitis and obtain appropriate cultures when indicated.
• Tell your patients to switch solutions if they are using ReNu with MoistureLoc. They can receive their money back or a coupon for another Bausch & Lomb product by visiting www.bausch.com or by calling 888.666.2258.
• Continue to remind patients who wear soft contact lenses to use safe handling and storage practices, and to follow the manufacturer's recommendations for wearing and changing the lenses. (See the Academy's Refractive Errors PPP for patient education and lens care recommendations.)

The CDC has not released any additional data or case reports, beyond what came out April 10 (see the Academy's April 11 member alert). An update is expected early next week. The Bausch & Lomb factory in South Carolina has been a focus of investigation, with no confirmed link yet. But as the company noted April 13: "However, in the cases of infections reviewed to date, the majority of patients reported using ReNu with MoistureLoc manufactured at our U.S. factory."

Investigations continue in Asia as well. The Singapore Ministry of Health issued a statement April 12 citing 75 cases of fungal keratitis between November 2004 and April 2006. The ministry repeated its recommendation that consumers stop using all ReNu brand multipurpose contact solution for the time being.