The U.S. Food and Drug Administration (FDA) has sounded the alarm on a nationwide recall of Systane brand eye drops, citing potential fungal contamination that could pose serious risks to eyesight.
Systane Lubricant Eye Drops Ultra PF, commonly used to temporarily relieve burning and irritation caused by dry eye symptoms, is now at the center of a nationwide recall. The product was distributed to multiple retail stores and online platforms.
Manufacturer Alcon Laboratories initiated the voluntary recall after a consumer reported foreign material inside a sealed single-use vial, which was later identified as fungal contamination.
“Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients,” the FDA stated in a news release.
The FDA has confirmed that no adverse events related to the recall have been reported so far. However, individuals experiencing quality issues or adverse reactions after using the product are encouraged to report them through the FDA’s MedWatch Adverse Event Reporting program. Complaints can be submitted online, by downloading and mailing the form, or via fax at 1-800-FDA-0178.
Each cardboard box of the product contains 25 sterile, single-use vials of lubricant solution for ophthalmic use. “The affected Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count is limited to lot number 10101, expiration date 2025/09. The product can be identified by the green and pink carton design, the presence of “Systane” and “ULTRA PF” brand names on the front of the carton, and the “25 vials” package size,” the news release stated.
Consumers who still have the products with them are advised to stop usage immediately and return to the place of purchase for a replacement or refund. Those who experience any issues potentially linked to the use of these eye drops should seek advice from a healthcare provider without delay.
As Alcon conducts its investigation, a spokesperson told NBC News that “the presence of foreign material appears to be isolated to the single unit returned by a customer.” They emphasized that the recall is being carried out, “out of an abundance of caution to prioritize consumer safety.” Those who have issues with the product can also contact them at 800-241-5999.
