Alcon Laboratories recalls a batch of Systane Lubricant Eye Drops due to potential fungal contamination, prompting concerns about eye health risks.
At a Glance
- One lot of Systane Lubricant Eye Drops Ultra PF recalled nationwide
- Recall triggered by consumer report of foreign material in sealed vial
- No adverse reactions reported, but potential for severe eye infections
- Consumers advised to stop using affected product immediately
- Recall is voluntary and conducted with FDA knowledge
Alcon’s Voluntary Recall: What You Need to Know
In a move that has caught the attention of eye care professionals and consumers alike, Alcon Laboratories has issued a voluntary nationwide recall of one lot of its popular Systane Lubricant Eye Drops. The recall, announced on December 21, 2024, and published by the FDA on December 23, 2024, specifically targets the Ultra PF Single Vials On-the-Go, 25 count (Lot 10101) due to concerns of fungal contamination.
The recall was initiated after a consumer reported finding a “foreign material” in a sealed single-use vial, which was later identified as fungal in nature. While no adverse reactions have been reported to date, the potential health risks associated with fungal contamination in ophthalmic products are severe enough to warrant immediate action.
A popular brand of eye drops is now being recalled nationwide due to a possible fungal contamination. Alcon Laboratories in Texas is voluntarily recalling Systane Lubricant Eye Drops Ultra P-F, the Food and Drug Administration announced.
https://t.co/hSFv7TQzq1— WXYZ Detroit (@wxyzdetroit) December 28, 2024
Health Risks and Precautionary Measures
The introduction of fungi into eye drops poses serious health concerns. According to the FDA, “If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients.” This stark warning underscores the importance of taking this recall seriously, particularly for those with compromised immune systems.
“Fungal contamination of an ophthalmic product is known to potentially cause eye infections,” the recall notice states.
Alcon Laboratories is taking this situation seriously, acting out of an “abundance of caution,” as stated by an Alcon spokesperson. The company is actively investigating the contamination, which appears to be an isolated incident. Consumers who have purchased the affected product are strongly advised to discontinue use immediately and return it for a refund or replacement.
Identifying the Affected Product
The recalled Systane Lubricant Eye Drops are packaged in a distinctive green cardboard box with 25 sterile, single-use plastic vials. They can be identified by the NDC 0065-1432-06 or UPC 300651432060, and have an expiration date of September 2025. The product is intended for temporary relief of burning and irritation caused by dry eye.
Alcon Laboratories is working diligently to notify distributors and customers about the recall and is arranging for product replacement. Retailers and distributors are instructed to discard any remaining stock of the recalled product to prevent further distribution.
Consumer Response and Reporting
Consumers who have concerns about potential reactions should consult their healthcare provider immediately. Additionally, any adverse reactions or quality problems experienced with the use of this product can be reported to the FDA’s MedWatch Adverse Event Reporting program online.
For those seeking more information or having questions about the recall, Alcon Laboratories has set up a dedicated line at 1-800-241-5999 during specified hours. The company is committed to addressing consumer concerns and ensuring the safety of its products.
This recall serves as a reminder of the importance of vigilance in healthcare product safety. As we continue to rely on over-the-counter medications for common ailments, it’s crucial to stay informed about potential risks and to follow recall instructions promptly to protect our health and well-being.
