The United States Food and Drug Administration announced earlier this week that one lot of eye drops is being voluntarily recalled due to potential fungal contamination.
Systane Lubricant Eye Drops Ultra PF are single vial drops sold in a 25-count box and manufactured by Alcon Laboratories in Fort Worth, Texas.
“Alcon evaluated a consumer complaint of foreign material observed inside a sealed single-use vial and determined the material to be fungal in nature,” according to a release issued by the FDA.
It is unclear what type of fungus has contaminated the eye drops.
Fungal contamination of eye products can cause eye infections, resulting in partial or total blindness. According to the FDA, in rare cases, such eye infections can be fatal to immunocompromised patients.
As of December 23, Alcon Laboratories had not received any reports of adverse events associated with the eye drop recall.
According to the FDA, Systane Lubricant Eye Drops Ultra PF are intended to temporarily relieve burning and irritation in people with dry eye symptoms.
The FDA advises consumers who have the recalled eye drops to stop using them immediately and return them to the place of purchase for a replacement or a refund. Distributors and retailers should also discard any boxes in stock bearing the lot number 10101.
The recall is limited to packages bearing the lot number 10101 and due to expire in September 2025. The FDA stated that packages were sold nationwide, both in stores and online.
The FDA advised consumers who used the recalled product and are experiencing problems to contact their health care provider right away.
“Alcon is conducting a voluntary recall of one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (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,” the company’s spokesperson said in a statement to ABC News.
“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,” according to the statement. “To date, there have been no adverse events associated with this recall.
However, in an abundance of caution, Alcon has issued a voluntary recall and notified the FDA. Our top priority is to ensure the safety of our products while remaining compliant with all regulatory bodies.”
Last year, contaminated eye drops caused at least four deaths and 14 cases of vision loss. At the time, patients said they used at least ten different brands of artificial tears.
The CDC reports that at least one set of eye drops was contaminated with an antibiotic-resistant strain of Pseudomonas aeruginosa, an aggressive bacterium.
In November, the FDA announced the recall of 27 eye drops due to potential safety concerns “after FDA investigators found insanitary conditions.”
