Certain eye drops are being recalled over potential fungus contamination, the Food and Drug Administration announced today.
Alcon Laboratories, the makers of Systane, voluntarily recalled one lot of their Systane Lubricant Eye Drops Ultra PF after a customer complained of “foreign material” in the drops.
After evaluating the complaint, Alcon determined that the material was “fungal in nature.”
Fungal contamination in eye drops can cause eye infections, which may be vision-threatening, and potentially life-threatening in people with compromised immune systems, Alcon said in a company announcement.
To date, there have been no health issues reported to Alcon in connection with the recalled eye drops.
The recall applies to Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count with the lot number 10101 and an expiration date of September of 2025. The product was distributed nationwide online and in stores, such as Target, Kroger, Walmart, and Walgreens.
The FDA is advising consumers who have the recalled eye drops to stop using them immediately and return them to where they were purchased for a refund or replacement.
The FDA is also urging consumers to contact their healthcare provider if they experience any health issues that may be related to the eye drops, and to report the problem to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.
FDA
Fungal eye infections are very rare, but can be serious.
The recall alert did not specify which type of fungi was found in the Systane eye drops, but many kinds of fungi can cause infection if they come in contact with eyes or spreads to the eyes from the bloodstream.
Symptoms of a fungal eye infection often appear between several days to several weeks after exposure. Common symptoms include:
Some groups—people who have diabetes, a weakened immune system, or use corticosteroids (anti-inflammatory steroids)—are at a higher risk of developing a fungal eye infection.
Contact your healthcare provider if you experience these symptoms after using the recalled eye drops, as diagnosis and treatment will vary.
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