Certain eye drops are being recalled due to potential fungal contamination, the Food and Drug Administration announced today.
Alcon Laboratories, the makers of Sistane, voluntarily recalled one batch of its Sistane Lubricant Ultra PF eye drops 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 can be vision-threatening and potentially life-threatening in people with compromised immune systems, Alcon said in a company statement.
To date, no health concerns have been reported to Alcon related to the recalled eye drops.
The recall involves Sistane Lubricant Ultra PF Eye Drops, On-the-Go Individual Bottles, 25 with lot number 10101 and an expiration date of September 2025. The product is distributed nationwide online and in stores such as Target, Kroger, Walmart and Walgreens.
The FDA advises consumers who have recalled eye drops to stop using them immediately and return them to where they were purchased for a refund or replacement.
The FDA also urges consumers to contact their healthcare provider if they experience any health problems that may be associated with the eye drops and to report the problem to the FDA’s MedWatch Adverse Event Reporting Program onlineby regular mail or fax.
Yeast infections of the eye are very rare but can be serious.
The recall warning did not specify which type of fungus was found in Sistana eye drops, but many types of fungus can cause infection if they come into contact with the eyes or are spread to the eyes from the bloodstream.
Symptoms of a fungal eye infection often appear between a few days to a few weeks after exposure. Common symptoms include:
Some groups – people who have diabetes, a weakened immune system or use corticosteroids (anti-inflammatory steroids) – have a higher risk of developing a fungal eye infection.
Contact your doctor if you experience these symptoms after using the recalled eye drops, as diagnosis and treatment will vary.