Systane Eye Drop Recall Lawsuit Filed Against Alcon Over Fungal Contamination Risk

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Alcon Laboratories faces a proposed class action lawsuit after it recalled one lot of its Systane lubricant eye drops due to a dangerous fungal contamination.

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According to the 18-page lawsuit, the defendant’s recall affects Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, specifically 25-count packages with the lot number 10101 and a September 2025 expiration date.

In an announcement published by the U.S. Food and Drug Administration on December 23, 2024, Alcon specifies that the recall was initiated following a consumer complaint about “foreign material” observed inside a sealed single-use vial.

The defendant determined the material was “fungal in nature” and could potentially cause eye infections, the case relays. Alcon urges consumers to stop using the recalled eye drops immediately, as infections may be vision-threatening and even life-threatening for immuno-compromised individuals, the announcement states.

The plaintiff, a Colorado resident, says she bought the adulterated Systane eye drops with the assumption that the product was sterile, as advertised on the item’s packaging. The woman claims she had to seek medical treatment after the eye drops caused her to experience red eyes, ocular swelling, itching and discharge.

Per the filing, the plaintiff and other consumers would not have purchased the Systane eye drops had they known there was a risk the product may contain a pathogen that poses a significant and severe health risk. The complaint asserts that affected consumers are entitled to refunds, which Alcon’s recall did not directly offer.

“[Alcon’s] failures to timely disclose the Product’s fungal contamination amount to negligent omission, and its representations that the Product was safe, STERILE, and of acceptable quality amount to negligent misrepresentation,” the Systane eye drop recall lawsuit claims.

The suit argues that the fungal contamination was a result of issues in Alcon’s manufacturing processes, quality control or packaging. Although the defendant remains silent about the precise reason for the eye drops’ contamination, the product’s active ingredient, polyethylene glycol, can serve as a carbon source for fungi, the case notes.

The lawsuit looks to represent anyone who purchased Alcon’s Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go (25 count) in Colorado for personal use.

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