Consumers who rely on Systane Lubricant Eye Drops Ultra PF for dry eye relief should take caution as the U.S. Food and Drug Administration (FDA) recently announced a voluntary recall of one lot due to possible fungal contamination.
The recall comes after a customer reported observing foreign material inside a sealed single-use vial, which was later identified as fungal matter, reported CBS News. This discovery raises concerns about the potential for eye infections, especially in individuals with compromised immune systems, prompting immediate action from the manufacturer and federal regulators.
The recalled eye drops were distributed in 25-count, single-use vials designed for on-the-go application.
The affected packages bear the lot number 10101 and an expiration date of September 2025. While the product is marketed to provide relief for dry eye symptoms, the presence of fungal contamination poses significant health risks. Fungal infections linked to eye products can lead to vision impairment and, in severe cases, life-threatening complications.
As a precaution, the FDA advises customers to stop using the product immediately and return it to the point of purchase for a full refund or replacement.
Alcon Laboratories, the manufacturer of Systane, emphasized that no adverse events related to this recall have been reported thus far. Despite this reassurance, health officials remain vigilant, encouraging consumers to monitor for eye irritation or infection symptoms, such as redness, swelling, or unusual discharge. The FDA advises affected individuals to consult their healthcare providers promptly if symptoms arise. This proactive approach aims to mitigate potential harm and ensure consumer safety amid growing concerns about product safety standards.
Alcon Laboratories has set up a dedicated helpline for inquiries regarding the recall. Consumers can contact the company at 1-800-241-5999 for assistance with returns and replacements.