Alcon Laboratories Issues Voluntary Nationwide Recall of One (1) Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), Due to Fungal Contamination

U.S. Food and Drug Administration sent this bulletin at 01/02/2025 08:04 AM EST

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US Food and Drug Administration

Alcon Laboratories Issues Voluntary Nationwide Recall of One (1) Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), Due to Fungal Contamination

**CVM is sharing these announcements because these products may be used in veterinary settings.**

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.

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