Systane eye drops may cause blindness, FDA warns

FDA warned Systane eye drops are contaminated with a fungus that could harm the eyes

Systane eye drops may cause blindness, FDA warns
Systane eye drops may cause blindness, FDA warns

Eye drops of the Systane brand were voluntarily recalled due to possible fungal contamination.

According to ABC News, the US Food and Drug Administration announced earlier this week that Systane Lubricant Eye Drops Ultra PF, a single vial of a 25-count box manufactured by Alcon Laboratories, based in Fort Worth, Texas, was recalled after the potential fungal contamination.

FDA wrote in its release, “Alcon evaluated a consumer complaint of foreign material observed inside a sealed single-use vial and determined the material to be fungal in nature.”

The FDA warned that fungal contaminations of eye products can lead to eye infections, resulting in partial or total blindness, and in rare cases it can be life-threatening.

Systane Lubricant Eye Drops Ultra PF helps to temporarily relieve burning and irritated eyes and provides temporary relief for people with dry eye symptoms.

Moreover, as of December 23, 2024, the manufacturers had not received any complaints or reports about any harm or bad reactions from the drop.

A company spokesperson told ABC News in a statement, “Alcon is conducting a voluntary recall of one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 counts (Lot 10101) distributed only in the United States following the discovery of foreign material inside a single, unused, plastic unit dose vial returned with a customer-reported complaint.”

“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. 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," the statement continued.

Furthermore, the FDA has recommended that people who have the recalled eye drops immediately stop using them and return to the place where they bought them and get a new pair or refund.