Last month, Alcon voluntarily recalled Systane Free Liquid Gel lubricant eye drops. No other formulations of Systane lubricant eye drops are included in the recall. This recall is in response to 11 consumer reports citing the presence of foreign material. Alcon has distributed more than 5 million bottles of Systane Free Liquid Gel since its introduction in January 2006. The product is distributed only in the United States, including Puerto Rico.
Tara Cortes, PhD, RN, president and CEO of Lighthouse International (left), with Donald J. D'Amico, MD. Lighthouse sponsored a lecture by Dr. D'Amico and reception to welcome him to New York City, where he is a new professor and Chair of Ophthalmology at the Weill Cornell Medical Center, and ophthalmologist-in-chief at New York Presbyterian Hospital.
After testing particles from the opened, partially used bottles that were returned to Alcon, the company identified the foreign material as mold. However, because of the characteristics of these molds, the development of an infection is considered unlikely. Alcon has received no reports of fungal infections associated with the 11 reports.
Alcon's testing of returned product and retained samples from the lots with reports of mold has determined that the cause of the product problem is the specific formulation of Systane Free Liquid Gel, and is not the result of any manufacturing processes. Therefore, the recall applies only to Systane Free Liquid Gel. The original formulation of Systane lubricant eye drops and Systane unit dose are not part of this recall and can continue to be used safely.
In addition, the company points out the other Alcon preservative systems are not affected. Systane Free Liquid Gel utilizes a combination of ingredients for antimicrobial activity, including borate, aminomethylpropanol (AMP), sorbitol and zinc that together contribute to the overall preservative system. The company's glaucoma drug, Travatan Z, uses an ionic buffered preservative system, sofZia, that is an extension of Alcon's borate/polyol preservative systems. Travatan Z solution does not contain any nitrogen source, such as AMP, which is present in Systane Free Liquid Gel. Nitrogen is an essential nutrient for the growth of microbial contaminants. Alcon has demonstrated that the sofZia preservative system withstands multiple challenges of high-levels of ocular pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus niger. Other in-use testing with high level challenges of Fusarium solani, Ralstonia pickettii, Staphylococcus epidermidis, Streptococcus pneumoniae, and Haemophilus influenzae demonstrated that Travatan Z solution is effectively preserved. SofZia preservative system meets the standards of preservative effectiveness required by the United States Pharmacopoeia.
Retailers, distributors, customers and consumers can identify if their bottles are subject to the recall by locating the words "Free" and "Liquid Gel" on the product box or bottle. If these words are not on the bottle or box, the product is safe for use and is not subject to this recall. For information, call 1 (866) 608-3936 or visit www.systane.com. The company is currently contacting retailers, distributors and eye doctors to communicate return and replacement instructions.
Alcon will replace any purchased bottles of Systane Free Liquid Gel with a 15mL bottle of its original formulation of Systane lubricant eye drops. The original formulation of Systane is based on the Polyquad preservative system that has been used for more than 20 years to prevent contamination of eye-care products. The original formulation of Systane has been used safely by consumers since 2003.
