Artificial tears manufacturer accused of false advertising in consumer class action

Long Island, N.Y. (CN) — A Long Island CVS shopper sued the Swiss-American pharmaceutical company Alcon for deceptive business practices on Thursday, accusing it of marketing its over-the-counter eye relief products as “sterile,” despite an April 2026 recall stemming from FDA inspection observations at the manufacturing facility.

While the Food and Drug Administration requires any drug used in the eyes to be sterile to reduce the risk of infection, Bibi Khan of Nassau County said in her class action complaint Alcon sold its  Systane Night Gel Comforting Dry Eye Relief and GenTeal Tears Lubricant Eye Gel products without an affirmative assurance of sterility.

Khan writes in her class action that the Systane Night Gel eye gel she purchased included a lot code of 1U63 and an expiration date of May 2026, indicating her specific purchase item was subject to Alcon’s recent recall.

“Consumers lack the meaningful ability to test or independently ascertain or verify whether an eye gel is actually sterile, especially at the point of sale, and therefore must and do rely on defendants to truthfully and honestly report the condition of the products,” she wrote in the complaint.

Consumers rely entirely on manufacturers’ claims that products meant for direct use in the eye are sterile, Khan wrote. Nonsterile eye products can introduce bacteria or fungi into the eye and cause serious, vision-threatening infections.

The class action also covers purchasers of GenTeal Tears Lubricant Eye Gel because it is substantially similar to the Systane Night Gel she purchased.

According to the FDA, both products were made at Excelvision Fareva, an Alcon contract facility in France with a documented history of dangerous mold contamination, including Penicillium citrinum, Fusarium oxysporum and Aspergillus.

Represented by New York attorney Brett R. Cohen of Leeds Brown, Khan seeks to certify nationwide and New York classes of consumers who paid a premium for the eye lubricants based on Alcon’s misleading marketing and labeling claims about sterility.

The complaint includes claims of deceptive business practices, negligence, unjust enrichment and breach of warranty.

Khan says Alcon breached its implied warranties by selling eye gels without sterility assurance and by failing to properly notify consumers of the defect.

According to the complaint, the proposed class action involves more than $5 million in claims.

The case has been assigned to U.S. District Judge Nina R. Morrison, a Joe Biden appointee.

Representatives for Fort Worth, Texas-based Alcon did not immediately respond to requests for comment on Friday.

FDA records show Alcon previously issued a recall in December 2024 for a similar product: one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, due to fungal infection.

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