Systane eye drops recalled due to potential fungal contamination

Systane eye drops have been recalled due to potential fungal contamination, the U.S. Food and Drug Administration announced.

The recall affects one lot of Systane Lubricant Eye Drops Ultra PF, which are sold in a 25-count box of single-use vials, according to the FDA. Alcon Laboratories, the Texas-based company that manufactures the eye drops, said it "evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined the material to be fungal in nature."

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The Systane Lubricant Eye Drops Ultra PF are used to temporarily relieve burning and irritation for people experiencing dry eye symptoms. The recall is limited to lot number 10101, which has an expiration date of September 2025. The products were sold nationwide in stores and online.

"Investigation of this event is still ongoing; however, the presence of foreign material appears to be isolated to the single unit returned by a customer," an Alcon spokesperson told ABC News. "To date, there are no adverse events related to this recall. However, out of an abundance of caution, Alcon has initiated a voluntary recall and notified the FDA. Our priority is ensuring the safety of our products while maintaining compliance with all regulatory bodies."

Fungal contamination of eye-related products can potentially cause eye infections, which can affect a person's vision or be life-threatening to immunocompromised patients, the FDA said. About 1 million people in the U.S. seek treatment each year for eye infections, which can result from bacteria, viruses, fungi and parasites invading the eye, according to the Cleveland Clinic. Symptoms of eye infections include red eyes, itching or irritation, eye pain, watery eyes, swelling, discharge and blurred vision.

People who have the recalled eye drops should stop using them immediately and return to where they were purchased for a replacement or refund. Anyone who used the recalled product and is experiencing symptoms should contact their healthcare provider, according to the FDA.