Alcon voluntarily recalls Systane Free Liquid Gel drops

Fort Worth, TX-Less than 1 year after introducing the product to the market, Alcon Laboratories Inc. voluntarily recalled Systane Free Liquid Gel lubricant eye drops after 11 consumer reports cited the presence of foreign material that the company later identified as mold.

The product, launched in January 2006, was recalled in December after the company had distributed more than 5 million bottles in the United States and Puerto Rico. No other formulations of Systane lubricant eye drops were included in the recall.

The company has not received any reports of fungal infections and considers the development of such infections unlikely because of the characteristics of the molds found when it tested opened, partially used bottles.

“Alcon is absolutely committed to providing the highest level of quality eye care products,” said Kevin Buehler, Alcon’s senior vice president, United States and chief marketing officer. “We took this voluntary action even though it is unlikely that eye infections would occur as a result of this issue.”

After testing returned product and retained samples and reviewing manufacturing records, Alcon determined that the cause of the problem was the product formulation, not manufacturing processes.

Eye drops subject to the recall contain the words “Free” and “Liquid Gel” on their boxes or bottles. In addition to immediately discontinuing use or distribution of the product, eye-care professionals, consumers, retailers, and distributors may obtain more information about the recall by calling 866/608-3936 or visiting www.systane.com. The company is contacting ophthalmologists and others to communicate return and replacement instructions. Reply cards and pre-paid mailing slips are being provided for product return.

Alcon will replace any purchased bottles of Systane Free Liquid Gel with 15-ml bottles of its original formulation of Systane. That formulation, in use without incident since 2003, is based on the Polyquad preservative system that has been used for more than 20 years to prevent contamination of eye-care products.

Annual sales of Systane Free Liquid Gel account for less than 10% of Alcon’s sales of artificial tears in the United States and Puerto Rico and less than two-tenths of 1% of Alcon’s total global sales. The company estimates that the pre-tax cost of the recall will be $8 million to $10 million but will not have a material impact on its projected sales or profits in 2007.

Alcon Laboratories is a subsidiary of Alcon Inc., which had sales of $4.4 billion in 2005.