Are Systane Eye Drops Safe? Lawsuit Alleges Fungal Contamination Puts Consumers at Risk

Case Overview: A class action lawsuit claims Systane Lubricant Eye Drops Ultra PF were contaminated with fungus, posing health risks to consumers. 

Consumers Affected: Consumers in Colorado who purchased Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25-count packages with lot number 10101.

Court: U.S. District Court for the District of Colorado

A recently filed class action lawsuit raises concerns about the safety of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, after fungal contamination led to a product recall. The lawsuit, filed in Colorado, alleges the manufacturer, Alcon Laboratories, sold eye drops advertised as sterile, despite the presence of fungal material discovered inside sealed vials.

Systane Eye Drops Recalled Due to Fungal Contamination

Colorado resident Kathy Even filed the proposed class action suit against Alcon, claiming the product was contaminated with fungus. The case centers on 25-count packages of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, specifically those with lot number 10101 and a September 2025 expiration date.

The lawsuit follows a December 2024 announcement published by the U.S. Food and Drug Administration, which confirmed the recall after a consumer reported seeing foreign material inside a sealed vial. According to Alcon, testing identified the material as fungal in nature, posing a risk of infection for users.

Alcon’s recall notice urged consumers to stop using the eye drops immediately, warning that fungal infections could threaten vision and, in some cases, life, particularly for individuals with weakened immune systems.

Lawsuit Alleges Alcon Failed to Ensure Sterility of Eye Drops

Even purchased the product in Colorado, relying on labeling that advertised the eye drops as sterile, safe, and suitable for regular use. After using the product, she experienced red eyes, swelling, itching, and discharge, ultimately requiring medical attention. The complaint claims the plaintiff would not have purchased the product had she known it carried any contamination risk.

The case alleges Even and others who purchased the affected product are entitled to full refunds, compensation for medical costs, and assurances that future products meet safety standards. Even further argues that Alcon’s recall process failed to offer consumers an automatic refund, requiring additional effort to recover the purchase price.

Allegations Highlight Alleged Manufacturing and Quality Control Failures

According to the complaint, fungal contamination may occur due to lapses in manufacturing procedures, quality control, or packaging protocols. Sterile products like eye drops must be produced in cleanroom environments, with proper air filtration, equipment sanitation, and employee hygiene protocols in place. Any failures in these processes can allow fungal spores to enter the product during production.

The filing also points to ingredient sterilization as a potential contamination source. Ingredients such as polyethylene glycol, which serves as a primary component in Systane eye drops, can support fungal growth if not properly sterilized before use. Defective packaging, including improperly sealed vials or non-sterile materials, may also create openings where contaminants enter after the product leaves the manufacturing floor.

The lawsuit claims Alcon has not publicly disclosed the precise manufacturing error responsible for the contamination, leaving consumers without clear answers. The lawsuit emphasizes that manufacturers bear responsibility for ensuring all sterile products meet required safety standards before they reach store shelves.

Consumers Paid Premium Prices for Eye Drops Marketed as Sterile

In her lawsuit, Even says that consumers purchasing Systane eye drops expect high-quality, sterile products free from contamination. Eye care products, particularly those designed for dry eyes or regular use, carry premium pricing compared to non-medical consumer goods. By failing to deliver sterile eye drops, the lawsuit claims Alcon misrepresented the product’s quality, causing economic losses for affected consumers.

Even alleges she would have chosen a different product or paid less if accurate information about potential fungal contamination had been provided at the time of purchase. The complaint states that other consumers in Colorado, who purchased the same product within the relevant period, are entitled to similar refunds and corrective action.

Other Eye Drop Products Face Similar Lawsuits

The case against Alcon follows several other recent lawsuits targeting eye drop manufacturers over contamination concerns. In May 2024, consumers filed suit against the makers of EzriCare Artificial Tears after bacterial contamination allegedly caused severe eye infections, vision loss, and, in some cases, fatalities. 

That case, like the Systane lawsuit, argues that consumers deserve safe, sterile products backed by reliable quality control at every stage of manufacturing and packaging.

In the Systane contaminated eye drops class action lawsuit, Even seeks to represent all Colorado residents who purchased Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25-count packages with lot number 10101. She is asking the court to require Alcon to issue full refunds to all class members and implement stricter manufacturing and quality control practices to prevent future contamination events.

Case Details

• Lawsuit: Even v. Alcon Laboratories Inc. et al
• Case Number: 1:25-cv-00574 
• Court: U.S. District Court for the District of Colorado

Plaintiffs' Attorney:

• Thiago M. Coelho, Chumahan B. Bowen, Jennifer M. Leinbach, and Reuben A. Aguirre (Wilshire Law Firm, PLC)

Have you used Systane Lubricant Eye Drops Ultra PF? Share your experience in the comments below.