A Medical Device Daily
Alcon Laboratories , a subsidiary of Alcon (both Fort Worth, Texas), on Friday reported recalling one of its liquid eye products contaminated with mold, thereby being one more in a series of product recalls for this industry over the past year.
It recalled its Systane Free Liquid Gel lubricant eye drops. The product is distributed only in the U.S. and Puerto Rico, the company said. It said that no other formulations of Systane lubricant eye drops are included in the recall.
The company said the recall is in response to 11 reports from consumers, citing the presence of “foreign material“ in the lubricant drops.
Alcon said it has distributed more than 5 million bottles of Systane Free Liquid Gel since the product was introduced this past January.
Thus far in 2006, Bausch & Lomb (B&L; Rochester, New York) and AMO (Santa Clara, California) also have had to recall contact lens cleaning solutions that appeared to be associated with fungal infections in the eye.
Alcon said that it tested particles from the opened, partially-used bottles of Systane that were returned to it, and that it identified the foreign material as mold.
It said that because of the characteristics of these molds, the development of an eye infection is considered unlikely“ and that it has received no reports of fungal infections associated with the 11 reports.
However, it also said that eye drops that become contaminated after opening the bottle may cause eye infections.
The company said that annual sales of the productaccount for less than 10% of its sales of artificial tears in the U.S. and Puerto Rico and less than two-tenths of 1% of total global sales. It estimates the pre-tax cost of the recall in the range of $8 million-$10 million. The company also said that the recall will not have material impact on its projected '07 sales or profits.
Alcon said it has notified the FDA concerning the recall.
In April, B&L recalled its ReNu with MoistureLoc contact lens solution in some markets including the U.S. (Medical Device Daily, April 17, 2006) and then in May extended that recall to all markets worldwide, saying the product may increase the risk of a potentially blinding eye infection called Fusarium keratitis. At the time it acknowledged that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in “unusual circumstances.“
More recently, in November, AMO voluntarily recalled 18 lots of its Complete MoisturePlus multi-purpose contact lens care solution and Active Packs in the U.S. after three lots sold in Japan were found to have bacterial contamination which compromised sterility (MDD, Nov. 22, 2006). The problem was traced to a production-line issue at AMO's manufacturing plant in China.
Alcon said that it tested the Systane products returned to it with reports of mold and reviewed its manufacturing records. As a result, it said it determined that the cause of the problem is the specific formulation of Systane Free Liquid Gel, not the result of any manufacturing processes. Therefore, the recall applies only to Systane Free Liquid Gel. The original formulation of Systanelubricant eye drops and Systane unit dose are not part of this recall “and can continue to be used safely,“ it said.
The company advised consumers to discontinue product use. It said it will replace any purchased bottles of the product with a 15mL bottle of its original formulation of Systanelubricant drops using a well-validated preservative system.
“Alcon is absolutely committed to providing the highest level of quality eye care products,“ said Kevin Buehler, Alcon's senior VP, U.S., and chief marketing officer, adding, that the company “took this voluntary action even though it is unlikely that eye infections would occur as a result of this issue.“
Alcon bills itself as is world's leading eye care company with 2005 sales of $4.4 billion.