Alcon recalls one lot of Systane single-use eye drops due to fungal contamination

Alcon Laboratories announced the voluntary recall of one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, following a consumer complaint that led to the discovery of fungal contamination in the drops.

“Investigation of this event is still ongoing; however, the presence of foreign material appears to be isolated to the single unit returned by a customer,” according to Alcon in a statement provided to Healio. “To date, Alcon has not received any reports of adverse events related to this recall. However, out of an abundance of caution, Alcon has initiated a voluntary recall and notified the U.S. FDA.”

Systane Lubricant Eye Drops Ultra PF are marketed for dry eye symptom relief and packaged in a cardboard carton containing 25 sterile, single-use vials of preservative free solution.

A customer reported observing a foreign material inside a sealed vial, and Alcon determined that it was fungal in nature, according to an announcement from the FDA.

Consumers are urged to immediately stop using Systane Lubricant Eye Drops Ultra PF and contact their eye care provider if they experience adverse symptoms, while distributors and retailers are advised to discard remaining stock of the drops.

“Our priority is ensuring the safety of our products while maintaining compliance with all regulatory bodies,” Alcon said.

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