Alcon Laboratories, based in Texas, has voluntarily recalled a specific lot of Systane Lubricant Eye Drops Ultra SPF, Single Vials On-the-Go after a potential fungal contamination was discovered, posing a risk of vision damage.
The U.S. Food and Drug Administration (FDA) announced the recall on Monday, affecting 25-count packages of the product. The recall was initiated following a consumer complaint about “foreign material” found inside a sealed vial. Upon investigation, Alcon confirmed the presence of fungal contamination in the affected batch.
This recall is part of a broader concern regarding the safety of eye drop products, with multiple similar incidents involving contamination reported over the past two years. In 2023 alone, several eye drop products were recalled due to similar issues.
Fungal contamination in eye care products can lead to serious eye infections, potentially impairing vision. In severe cases, particularly among immunocompromised individuals, such infections may become life-threatening.
While Alcon has not received reports of infections linked to this specific batch of eye drops, consumers who purchased the product are advised to check the lot number, expiration date, and other packaging details to confirm whether their purchase is part of the recall.
Details for the recalled product:
Lot Number: 10101
UPC: 300651432060
NDC: 0065-1432-06
Expiration Date: September 2025
The affected eye drops were distributed across retail stores and online retailers nationwide. Consumers who have experienced adverse effects after using the recalled eye drops are encouraged to report their experiences through the FDA’s MedWatch Adverse Event Reporting program.
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