The Ministry of Health (MoH), via its Chemistry, Food and Drugs Division, is advising the public of the voluntary recall of Lot 10101 of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go.
Systane Lubricant Eye Drops is used for the temporary relief of burning and irritation in persons experiencing dry eye symptoms.
In its advisory, the Health Ministry explains that the recall was issued by Alcon Laboratories and follows a report of foreign material found in a sealed single-use vial, which was determined to be fungal in nature.
“Fungal contamination of an ophthalmic product is known to potentially cause eye infections,” said an official statement issued by Alcon Laboratories.
“If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients,” the company said.
The Health Ministry notes that to date, Alcon Laboratories has not received any reports of adverse events related to this recall. It also points out that the local distributor of the eye drops has confirmed that none of the affected products—presentation and lots—were imported into Trinidad and Tobago.
The Ministry is advising persons who may be in possession of the identified batch of Systane Lubricant Eye Drops—namely, Lot 10101—to discontinue use immediately, and to return the product to the place of purchase where possible.
“The Ministry of Health will continue to monitor the situation and advise the population as necessary,” the bulletin assured.
For more information, the public is encouraged to contact the Office of the Director of the Chemistry, Food and Drugs Division via email, at cfdd@health.gov.tt, or via phone at 217-4664 Ext. 13101.