A lot of Systane Lubricant Eye Drops Ultra PF has been voluntarily recalled by the manufacturer.
On December 21, Alcon Laboratories issued a voluntary nationwide recall of its product, Systane Lubricant Eye Drops Ultra PF, due to a consumer complaint of foreign material observed inside a sealed single use vial and determined the material to be fungal in nature.
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, presence of “Systane” and “ULTRA PF” brand names on the front of the carton, and the “25 vials” package size. (Please see product image.) Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) was distributed nationwide to retail and internet outlets.
In its statement also posted on the FDA’s site, the company said: “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.”
Consumers that have the recalled Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, should stop using them immediately and return them to the place of purchase for a replacement or refund. Consumers with questions regarding this recall can contact Alcon Laboratories at 1-800-241-5999 between 7:30am and 6:00pm (Central), Monday to Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
As of December 21, the company reported no adverse events linked to the product. “Alcon Laboratories has not received any reports of adverse events related to this recall.”
