The FDA reported last month that Alcon Laboratories is voluntarily issuing a nationwide recall of one lot of Systane Lubricant Eye Drops Ultra Preservative-Free (PF) due to the risk for fungal contamination.
Let’s start with this product.
Formulated with the active ingredients of polyethylene glycol 400 0.4% and propylene glycol 0.3%, these Systane eye drops are intended to be instilled as one or two drops into the affected eye(s).
- The intended purpose: To provide temporary dry eye symptom relief of burning and irritated eyes.
The drops are packaged in 10 ml multi-dose bottles as well as 25- and 30-count single-use vials.
And in the case of the recall?
Exactly one 25-count lot (Lot 010101) of single-use, on-the-go, low-density polyethylene (LDPE) plastic vials (NDC 0065-1432-06, UPC 300651432060) with an expiration date of 2025/09.
This lot was distributed nationwide to retail and internet outlets, according to the FDA.
For a visual of the product, click here.
So what led to this?
Alcon issued the voluntary recall on Dec. 21, 2024, following a consumer complaint of “foreign material” observed inside a single, unused, plastic unit dose that was later returned, according to the company.
Upon investigation, Alcon “determined the material to be fungal in nature,” the FDA reported.
Take note: The affected lot was distributed only in the United States.
And the potential risk?
Fungal contamination of an ophthalmic product is known to potentially cause eye infections that may be vision-threatening and (though rare) potentially life-threatening in immunocompromised patients.
Such contamination is also associated with a complication of contact lens wear, leading to symptoms such as eye pain, redness, blurred vision, and excessive tearing.
To note: These Systane eye drops are marketed as safe for use with soft contact lenses.
Have there been any reports of adverse events?
As of Jan. 2, 2025, the company reported no confirmed adverse events related to the recall.
An Alcon spokesperson told Glance that, while investigation into the event remains ongoing, it appears to be isolated to the single unit returned by a customer.
Further, the recall and FDA notification were made out of an “abundance of caution.”
So what steps has the company taken?
Alcon is reported to be notifying its distributors and customers via email, letter, and phone to arrange for replacements of all recalled products.
The FDA advised distributors/retailers to discard any remaining stock of the affected lot (once again: Lot 10101).
What should I do if my patient has used drops from this affected lot?
Consumers are advised to immediately stop use of the drops and return to their place of purchase for a refund.
For any concerns regarding a potential reaction to the product, patients should reach out to their eyecare professional, the FDA stated.
For any questions regarding the recall, Alcon can be reached at 1-800-757-9780 between 8 am and 5 pm CST between Monday and Friday.
And if I need to report an adverse event?
Submit a form online via the FDA’s MedWatch Adverse Event Reporting program or by mail/fax.