AAFES RECALL NO.
06-049 |
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WORLDWIDE Alcon Labs, in cooperation with FDA, is voluntarily recalling Systane Free Liquid Gel Lubricant Eye Drops 10ml. for mold contamination. HAZARD: This voluntary recall is in response to 11 consumer reports citing the presence of foreign material. 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 Labs is voluntarily recalling SystaneŽ Free LIQUID GEL because eye drops that become contaminated after opening the bottle may cause eye infections. The recall applies only to SystaneŽ Free LIQUID GEL. The original formulation of SystaneŽ lubricant eye drops and SystaneŽ unit dose are not part of this recall and can continue to be used safely. The original formulation of SystaneŽ is based on the PolyquadŽ preservative system that has been used for more than 20 years to prevent contamination of eye care products. Furthermore, the original formulation of SystaneŽ has been used safely by consumers since 2003. DESCRIPTION: Systane Free Liquid Gel Lubricant Eye Drops 10ml. UPC #: 3 0065 0428 15 6 INSTRUCTIONS FOR CUSTOMERS: Consumers who are in possession of SystaneŽ Free LIQUID GEL should immediately discontinue use and call 1-866-608-3936 or visit www.systane.com for instructions. Alcon will replace any purchased bottles of SystaneŽ Free LIQUID GEL with a 15mL bottle of its original formulation of SystaneŽ lubricant eye drops. 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. Home
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