Systane Eye Drops Recall Issued Due to Risk Single-Use Vials May Be Contaminated

Fungal contamination of Systane “On-the-Go” eye drops may cause users of the single vials to experience severe eye irritation and a potential risk of vision loss.

Alcon Laboratories has issued a voluntary recall for Systane Lubricant Eye Drops Ultra PF, which were sold in single-use “On-the-Go” vials, due to potential fungal contamination that could expose users to a risk of severe health consequences, including eye irritation and potential vision loss.

Systane Lubricant Eye Drops are marketed for the temporary relief of burning eye irritation symptoms caused by having dry eyes, with the fluid contained in single-use plastic vials with a tip that can be torn off.

The U.S. Food and Drug Administration (FDA) announced the eye drop recall on December 23, indicating that at least one lot of the Systane “On-the-Go” Eye Drops may be contaminated by a fungus, which could lead to eye infections and vision loss for some users, or death for those who are immunocompromised.

Alcon first became aware of the issue after a customer complained about foreign matter that was observed in a vial of Systane Eye Drops. A company investigation determined that the contaminant was fungal in nature, and could lead to severe adverse health consequences if used.

As a result, the manufacturer issued a voluntary recall of one lot of the product on December 21. At the time, no injuries or deaths had been reported as a result of the recalled product.

The affected Systane Eye Drops is limited to lot number 10101, with an expiration date of 2025/09. The eye drops are sold in a green and pink carton, which contains 25 single-use LDPE vials of sterile solution each. The brand names “Systane” and “Ultra PF” appear on the front of the carton, as well as the package size of “25 vials.”

Distributors will be notified by letter, email or phone, and are eligible for a replacement of any recalled products.

Customers who are still in possession of the affected lot of Systane Eye Drops should immediately stop using them and return the package to the place of purchase for a refund or replacement. Those who experience adverse reactions should contact their healthcare providers immediately.

Questions regarding the recall can be directed to Alcon Laboratories, which can be reached at 1-800-241-5999 between 7:30 a.m. and 6:00 p.m. (CT), Monday to Friday.

Customers can also report any illnesses or quality problems to the FDA’s MedWatch Adverse Event Reporting program online, or by downloading the appropriate form and returning it by fax to 1-800-FDA-0178 or by regular mail to the address on the form.