FDA MedWatch - One Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) by Alcon

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TOPIC: One Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) by Alcon: Recall - Due to Fungal Contamination

AUDIENCE: Consumer, Patient, Pharmacy, Ophthalmology 

ISSUE: Alcon Laboratories is recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count because Alcon evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined the material to be fungal in nature. 

Risk 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.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Systane Lubricant Eye Drops Ultra PF are used for the temporary relief of burning and irritation in persons experiencing dry eye symptoms.

RECOMMENDATIONS: 

• Consumers/patients should contact their physician or health care provider if they have experienced any problems that may be related to using this drug product.

• Consumers/patients that have the recalled Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) which is being recalled should stop using them immediately and return to the place of purchase for a replacement or refund.

• Consumers/patients with questions regarding this recall can contact Alcon Laboratories at 1-800-241-5999.

• Alcon Laboratories is notifying its distributors and customers by letter, email, and/or phone call and is arranging for replacement of all recalled products.

• Distributors or retailers should discard any remaining stock of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101).

Health care professionals, patients and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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