To Our Patients
Due to possible fungal contamination, Alcon Laboratories is recalling a small batch of Systane Lubricant Eye Drops Ultra PF.
The recalled product comes in 25-count packages with lot number 10101 and a September 2025 expiration date.
Note that fungi are omnipresent in the world, and we are exposed to them during our daily lives. Fortunately, fungal eye infections are very rare. The affected eye drops, however, may increase the risk for fungal eye infections in patients that have had recent trauma or have other active eye disorders.
What to Do to Stay Safe
Though there have been no reports of users having adverse reactions from the contaminated vials, if you have this product, do not use it. Return it to your original place of purchase for a replacement or refund.If you have used this product and are worried about potential infection, please notify our office. Also, we are ensuring that our samples of artificial tears do not include the affected product.
More About the Recall
On December 21, Alcon Laboratories voluntarily recalled the select vials after evaluating a consumer complaint of foreign material observed inside a sealed single-use vial and determining that material to be fungal in nature.
Alcon Laboratories officially registered the recall with the U.S. Food and Drug Administration (FDA), which posted an official press release on its website on December 23.
Alcon Laboratories has notified its distributors of the contamination and is arranging for the replacement of all recalled products.
More About Systane Lubricant Eye Drops Ultra PF
Systane Lubricant Eye Drops Ultra PF is used for the temporary relief of burning and irritation in persons experiencing dry eye symptoms and is packaged in a cardboard carton containing 25 sterile, single-use LDPE plastic vials of preservative-free solution for ophthalmic use (NDC 0065-1432-06, UPC 300651432060).
The affected Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25-count is limited to lot number 10101, with an expiration date of September 2025. The product can be identified by the green and pink carton design, presence of “Systane” and “ULTRA PF” brand names on the front of the carton, and the “25 vials” package size. Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) was distributed nationwide to retail and internet outlets.Questions or concerns about the recalled eye drops? Please call Eye Consultants of Atlanta at 404-351-2220 or Alcon Laboratories at 1-800-241-5999.
