FORT WORTH, TX: On December 21, 2024, Alcon Laboratories announced that it had recalled a single lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count, because of a fungal contamination.
The company said the consumer-level recall was initiated after one consumer reported discovering foreign material inside a sealed, single-use vial of the product. Further evaluation revealed the material’s fungal nature.
Consumers are advised that using ophthalmic products contaminated with fungus could put them at risk for eye infections, which may cause blindness. In certain rare cases, those who are immunocompromised could also be subject to life-threatening conditions.
Indicated to temporarily relieve “burning and irritation” in “dry eye symptoms”, Systane Lubricant Eye Drops Ultra PF was distributed to retail and internet outlets across the U.S. It comes in a cardboard carton that holds 25 “sterile, single-use LDPE plastic vials of preservative free solution for ophthalmic use.” The recall only covers products found under Lot 10101, bearing NDC 0065-1432-06, and UPC (Universal Product Code) 300651432060. As shown by the photo attached to the FDA announcement, consumers can identify the product by the green and pink design of its carton. The brand names “Systane” and “ULTRA PF,” as well as the “25 vials” package size, appear prominently on the carton’s front.
While the company has not received any reports of adverse reactions as of this writing, anyone who may have purchased any recalled units from Lot 10101 of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count is asked to cease all use of the product. Those seeking to replace their purchase or access a refund are asked to return the item to the point of purchase.
Representatives at Alcon Laboratories are able to answer questions regarding the recall at 1-800-241-5999. Phone calls are monitored Monday through Friday, from 7:30 a.m. to 6:00 p.m. Central Time. Those experiencing any problems believed to be linked to the use of the problem are instructed to contact their physician as soon as possible.
By the time of the December 23, 2024, FDA announcement, the company had already begun alerting its distributing partners and customers via phone call, email, and letter. A replacement program for all recalled products had also been established. Any leftover stock belonging to Lot 10101 of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count still carried by distributors or retailers should be safely discarded.
As the FDA continues to carry out the recall, consumers are urged to report any related adverse events or quality issues to the agency’s MedWatch Adverse Event Reporting program.
If you have suffered an infection or another adverse health outcome that can be traced to a fungal contamination in a medical drug, we would like to learn about your case and advocate for the compensation you deserve. Our attorneys at Oliver Law Office (Contact Oliver Law Office) have a range of experience in mass tort litigation and are committed to holding at-fault parties accountable for pain and suffering. Please connect with us today by calling 614-220-9100 or by completing this online contact form.