Alcon Laboratories issues recall for Systane eye drops due to fungal contamination

Systane eye drops recall overview: 

• Who: Alcon Laboratories is recalling one lot of its Systane Lubricant Eye Drops. 
• Why: The eye drops may be contaminated with a fungus.
• Where: The Systane eye drops recall is active in the United States.

Alcon Laboratories has recalled one lot of its Systane Lubricant Eye Drops as the eye drops may be contaminated with a fungus.

The recall was published to the U.S. Food & Drug Administration website on Dec. 23. It applies to Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count, lot number 10101 with an expiration date of 2025/09. 

According to the notice, the recall came about after a consumer complained that they saw “foreign material” inside a sealed, single-use vial of the eye drops. 

Alcon said it evaluated the complaint, and found that the foreign material was some sort of fungus. 

“Fungal contamination of an ophthalmic product is known to potentially cause eye infections,” the recall says. “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 the recall, it said. The company is not currently facing legal action, but Top Class Actions follows recalls closely, as they can sometimes result in lawsuits.

Alcon Laboratories offers replacement or refund

The affected eye drops were distributed nationwide to retail and internet outlets, the recall says. 

The product can be identified by the green and pink carton design, presence of “Systane” and “ULTRA PF” brand names on the front of the carton, and the “25 vials” package size.

Consumers that have the recalled Systane eye drops should stop using them immediately and return to the place of purchase for a replacement or refund, the notice says.

In November, Similasan Corp., a Swiss company known for its homeopathic eye drops, agreed to a $3.57 million settlement after being accused of selling its products as drugs without U.S. Food and Drug Administration approval and failing to meet necessary safety standards.

Are you affected by this Systane eye drops recall? Let us know in the comments. 

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