Fungal contamination leads to recall of eye drops: Affected Systane products listed
Some Systane eye drops have been voluntarily recalled due to concerns about possible fungal contamination, which can result in eye infections and may endanger users’ vision, as stated in a recent recall notice from the Food and Drug Administration (FDA).
According to the FDA recall announcement, Alcon Laboratories recalled one batch of Systane Lubricant Eye Drops Ultra PF. This action followed a consumer report that described finding foreign material in a sealed single-use vial of the eye drop solution.
The FDA report confirmed that the material was identified as “fungal in nature.”
No adverse reactions from the affected vials have been reported thus far.
How can I find out if my eye drops are affected?
According to the FDA, the following product has been recalled:
- Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count: Lot 10101, with an expiration date of September 2025.
These eye drops are designed to provide temporary relief from “burning and irritation” related to dry eye symptoms.
The eye drops come in a green and pink box labeled with the Systane and ULTRA PF brand names, as per the FDA. Inside, there are 25 plastic vials of the solution.
To locate the product’s lot number, check the bottom of the box and the individual vials.
Alcon Laboratories is reaching out to retailers and consumers who bought the product through letters, emails, or phone calls.
Where was this product sold?
The eye drops were distributed across the country, available in various retail outlets and online platforms.
According to a recall notice dated December 20, these products have been sold at Publix.
What risks do the recalled eye drops pose?
The contaminated eye drops could lead to an eye infection, as indicated in the recall notice.
An infection from these drops might jeopardize a person’s eyesight, and in rare instances, it could be life-threatening for individuals with weakened immune systems.
What should consumers do with the recalled eye drops?
Consumers should stop using these eye drops immediately and return them to the store where they were purchased for either a replacement or a refund, as advised by the FDA.
Individuals who have used or bought the recalled eye drops and are experiencing adverse effects or issues with the product can report these incidents to the FDA’s MedWatch Adverse Event Reporting. To file a report, consumers can:
- Submit a report online
- Download a form using the provided link or call 1-800-332-1088 to ask for a reporting form, fill it out, and mail it to the address on the pre-addressed form
- Send the form via fax to 1-800-FDA-0178