Alcon Announces Voluntary Recall of Systane® Free LIQUID GEL Lubricant Eye Drops in the United States, Including Puerto Rico
No Other Systane® Formulations Affected by Recall
Alcon Investor Relations
Alcon Strategic Corporate Communications
Alcon Laboratories, Inc., a subsidiary of Alcon, Inc. (NYSE: ACL), announced a voluntary recall of Systane Free LIQUID GEL lubricant eye drops. This product is distributed only in the United States, including Puerto Rico. No other formulations of Systane lubricant eye drops are included in this recall. This voluntary recall is in response to 11 consumer reports citing the presence of foreign material. Alcon has distributed over 5 million bottles of Systane Free LIQUID GEL since its introduction in January 2006.
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. In fact, Alcon has received no reports of fungal infections associated with the 11 reports. The company is taking this action to voluntarily recall Systane Free LIQUID GEL because eye drops that become contaminated after opening the bottle may cause eye infections. Alcon has notified the U.S. Food and Drug Administration of this voluntary action.
Alcon has tested returned product and retained samples from the lots with reports of mold and has conducted a comprehensive review of its manufacturing records. Based on this testing and analysis, Alcon 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.
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. The picture provided shows where these words are found on the bottle and box.
Consumers who are in possession of Systane Free LIQUID GEL should immediately discontinue use and call 1-866-608-3936 or visit www.systane.com for instructions. The company is currently contacting retailers, distributors and eye doctors to communicate return and replacement instructions. These customers may also call 1-866-608-3936 for more information. 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 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. Furthermore, the original formulation of Systane has been used safely by consumers since 2003.
To reduce the potential for contamination of eye drops, consumers should not touch the tip of the bottle to their eye, should not allow anything else to touch the tip of the bottle and should always put the cap on the bottle immediately after use. Consumers who have concerns about the health of their eyes or who experience unusual eye symptoms, such as severe pain, loss of vision, or significantly increased sensitivity to light, should consult with their eye doctor immediately.