The Health Ministry is advising of a voluntary recall for Systane Lubricant Eye Drops.
This is for lot 10101 of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, which are used for the temporary relief of burning and irritation in persons experiencing dry eye symptoms.
Issued by Alcon Laboratories, the recall follows a report of foreign material found in a sealed single-use vial, which was determined to be fungal in nature.
The company has issued the following statement: “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”.
To date, Alcon Laboratories has not received any reports of adverse events related to this recall.
The local distributor has also confirmed that none of the affected products (presentation and lots) were imported into T&T.
However, out of an abundance of caution, the Ministry is advising persons who may be in possession of the identified batch of drops to discontinue use immediately and return the product to the place of purchase where possible.
Additional information can be obtained by contacting the Office of the Director of the Chemistry, Food and Drugs Division via email at cfdd@health.gov.tt or phone at 217-4664 ext. 13101.
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