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The U.S. Food and Drug Administration (FDA) announced a nationwide recall of an eye drops brand due to fungal contamination.
“Alcon Laboratories is voluntarily recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the consumer level. 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 stated.
“Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients. To date, Alcon Laboratories has not received any reports of adverse events related to this recall,” it added.
Systane brand eye drops were voluntarily recalled due to possible fungal contamination, the Food and Drug Administration said. https://t.co/RJqbzLSIVD
— NBC News Health (@NBCNewsHealth) December 25, 2024
From the New York Post:
Fungal contamination in eye drops can cause eye infections, which can threaten vision and in rare cases can be fatal in people who are immunocompromised.
The Systane Lubricant Eye Drops Ultra PF being recalled are sold in boxes of 25 single-use vials and are marketed to offer “fast-acting hydration and lasting relief.”
Only packages in with the lot number 10101 with an expiration date of September 2025 are being recalled; however, they were distributed throughout the US in retail stores and online.
Alcon Laboratories in Texas is voluntarily recalling Systane Lubricant Eye Drops Ultra P-F following a consumer complaint of foreign material that could be observed inside a sealed vial. https://t.co/YVpmJE0MIX
— Jeffrey A. Setaro (@jasetaro) December 25, 2024
Eye drops have been recalled due to the possibility of fungal contamination. https://t.co/7iy2Got05G pic.twitter.com/VcQX8jUXLW
— azfamily 3TV CBS 5 (@azfamily) December 24, 2024
Per NBC News:
The product was sold at Publix, according to a notice from the grocery chain.
The drops are used to treat burning and irritation in people experiencing dry eye symptoms.
Anyone who has purchased the eye drops should stop using them immediately and can seek either a refund or replacement, the FDA said. If anyone is experiencing symptoms, they should consult with their physician.
Steven Smith, an Alcon spokesperson, said that the company’s investigation is ongoing, but “the presence of foreign material appears to be isolated to the single unit returned by a customer.”
Alcon recalled the product “out of an abundance of caution to prioritize consumer safety,” he added.
Read the full FDA release HERE.