Warning for New Yorkers Regarding Recalled Eye Drops

Alcon Laboratories has voluntarily initiated a nationwide recall of one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) due to concerns of fungal contamination. This recall was announced on December 21, 2024, with the FDA publishing the details on December 23, 2024.

Reason for Recall

The recall was prompted by a consumer report regarding foreign material found inside a sealed single-use vial, later confirmed to be fungal in nature. Fungal contamination in ophthalmic products can potentially lead to eye infections, which may pose a risk of vision-threatening consequences, especially for immunocompromised individuals. As of now, there have been no adverse events reported related to this recall.

Product Description

Systane Lubricant Eye Drops Ultra PF is commonly used for temporary relief of burning and irritation in individuals experiencing dry eye symptoms. The product is presented in a cardboard carton containing 25 sterile, single-use LDPE plastic vials of preservative-free solution for eye use.

Identification of Affected Product

The recalled product, Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), can be recognized by the lot number and an expiration date of September 2025. It is distinguished by its distinctive green and pink carton design, brand name labeling, and package size of 25 vials.

Consumer Actions

Consumers who have purchased the recalled eye drops are advised to immediately discontinue use and return the product to the store of purchase for a refund or replacement. For any questions related to the recall, individuals can contact Alcon Laboratories at 1-800-241-5999 between 7:30 AM and 6:00 PM (Central Time) on weekdays.

Distribution and Communication

Alcon Laboratories is actively notifying its distributors and customers through various channels, including letters, emails, and phone calls. Retailers are urged to discard any remaining stock of the recalled product.

Reporting Adverse Reactions

Consumers who have encountered adverse reactions or quality concerns related to the use of the recalled eye drops are encouraged to report them through the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax.

Collaboration with FDA

The recall is being conducted in collaboration with the U.S. Food and Drug Administration (FDA) to ensure public safety and awareness regarding the issue.

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Contact Information for Consumers

For further information or assistance, consumers can reach out to Alcon Laboratories at 1-800-241-5999.