Class Action Lawsuit Filed Over Systane Eye Drops Recalled Due to Fungal Contamination

Class Action Lawsuit Filed Over Systane Eye Drops Recalled Due to Fungal Contamination

A class action lawsuit alleges that consumers were misled into purchasing Systane eye drops, which were marketed as safe and effective, before a massive recall was issued late last year due to a risk of fungal contamination.

The complaint (PDF) was filed by Kathy Even in the U.S. District Court for the District of Colorado on February 20, naming Alcon Laboratories Inc. as the defendant, and seeks class action status to pursue damages onbehalf of all individuals who purchased the recalled eye drops.

Systane Lubricant Eye Drops were marketed for the temporary relief of burning eye irritation symptoms caused by having dry eyes, and are sold in single-use plastic vials, with a tip that can be torn off.

However, on December 23 the U.S. Food and Drug Administration (FDA) announced a Systane “On-the-Go” Eye Drops recall, warning that at least one lot may carry fungal contamination, which could lead to serious eye infections, vision loss and even death for those with compromised immune systems.

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According to the lawsuit, Even, of Colorado, purchased the eye drops based on claims that they were sterile and safe for their advertised use. Even claims that she would not have purchased the products if she had known there was a risk they were contaminated.

In addition to physical injuries, including red eyes, ocular swelling, itching and discharge, which led to Even seeking medical attention from an eye doctor, she also indicates she and other consumers suffered financial damages by buying the dangerous products.

“Plaintiff was required to seek medical attention from an eye doctor because she used the adulterated Product for months and fears future injury caused by prior use of the Product,” the lawsuit states. “Plaintiff would purchase similar Product in the future provided it is not adulterated or contaminated.”

Even noted that she received a product recall notice on December 24, which urged consumers to stop using the eye drops immediately. However, the recall did not direct Even or other consumers on how to get a refund for their purchases.

The lawsuit defines class participants as all consumers who purchased Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go. It presents claims of negligent misrepresentation/omission, breach of warranty, unjust enrichment, and Violations of the Colorado Consumer Protection Act.


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