Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Fort Worth, TX — Alcon Laboratories has issued a voluntary nationwide recall of one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) due to potential fungal contamination. The recall affects only the specific lot number 10101, with an expiration date of September 2025.
The company’s decision to recall the product follows a consumer complaint in which foreign material was observed inside a sealed single-use vial. Upon investigation, Alcon confirmed the presence of fungal contamination in the affected lot.
Fungal contamination in an ophthalmic product can pose serious health risks, potentially leading to eye infections that may threaten vision. In rare cases, such infections could become life-threatening, particularly for immunocompromised individuals. Alcon Laboratories has stated that, as of now, no adverse events have been reported in connection with this recall.
The affected product, Systane Lubricant Eye Drops Ultra PF, is used for temporary relief of burning and irritation caused by dry eye symptoms. It is packaged in a 25-count carton, containing single-use vials of preservative-free solution for ophthalmic use. The product can be identified by the green and pink design on the carton, along with the brand names “Systane” and “ULTRA PF.”
Alcon is advising consumers who have purchased the affected lot (Lot 10101) to immediately stop using the product and return it to the place of purchase for a replacement or refund. Retailers and distributors have been instructed to discard any remaining stock of the recalled product.
Consumers with questions or concerns can contact Alcon Laboratories at 1-800-241-5999 from 7:30 AM to 6:00 PM (Central), Monday through Friday. Additionally, anyone who has experienced adverse reactions related to the use of this product is encouraged to report them to the FDA’s MedWatch Adverse Event Reporting program.
Alcon is working with its distributors and retailers to ensure the removal of the affected products and replacement for consumers. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
