The U.S. Food and Drug Administration (FDA) is warning that people who use eye drops recalled over fungal contamination are risking vision damage and potential death.
A recall notice shared to the FDA website on Monday informs consumers that Fort Worth, Texas-based Alcon Laboratories recalled some packages containing 25 single vials of “on the go” Systane Lubricant Eye Drops “Ultra PF” after an unnamed fungus was found floating in the solution.
The company issued the recall on Saturday and said that the issue was detected after “a consumer complaint of foreign material observed inside a sealed single use vial” led to an investigation that “determined the material to be fungal in nature.”
“Fungal contamination of an ophthalmic product is known to potentially cause eye infections,” the notice states. “If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients.”
The recall applies only to products from lot number “10101” with an expiration date of “2025/09.” The eye drops are packed in a cardboard carton of 25 single-use plastic vials with the NDC number “0065-1432-06” and the UPC number “300651432060.” The product is sold online and in retail stores across the U.S.
The company said that it was notifying “distributors and customers by letter, email, and/or phone call and is arranging for replacement of all recalled products,” while urging distributors and retail outlets to “discard any remaining stock.”
Newsweek reached out for comment to Alcon Laboratories via email on Monday.
While there had not been any illnesses or other “adverse events” associated with the recall when it was issued, Alcon asked any consumers who believe that they did experience an adverse reaction to inform the FDA’s MedWatch Adverse Event Reporting program.
Serious problems can be reported to the MedWatch program online or by downloading a form or calling 1-800-332-1088 to request a form before filling it out and returning it via mail or fax.
Symptoms of an eye infection can include pain or discomfort in one or both eyes, blurry vision, excessive tearing, crust in or around the eyeball or eye redness. A medical professional should be contacted if any of these symptoms are experienced after using the recalled eye drops.
Fungal eye infections “are extremely rare but can be very serious,” according to the U.S. Centers for Disease Control and Prevention (CDC). Fungus can cause either keratitis—an infection of the outer layer of the eye—or endophthalmitis, an inner eye infection.
People who have a weakened immune system, conditions like diabetes or use steroids for other medical issues are most at risk for fungal eye infections. The infections are typically treated with anti-fungal eye drops and medications, although surgery may be required in some cases.
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