December 26, 2024
Alcon has not received any reports of adverse events related to this recall, however, the company is taking precautions to ensure consumer safety.
On December 21, Alcon Laboratories issued a voluntary recall of its Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, one lot of 25 (Lot 10101) following a consumer complaint. revealed the presence from a foreign material later identified as fungal.
The recalled product, which is commonly used to temporarily relieve dry eye symptoms, poses a significant health risk if contaminated. The ophthalmic product can cause serious eye infections that can lead to vision loss. Infections can be life-threatening in sporadic cases , especially in immunocompromised individuals.
Alcon has not received any reports of adverse events related to this recall, however, the company is taking precautions to ensure consumer safety.
Details of the recalled product
The recall is limited to 10,101 lots, which expire in September 2025. The product is packaged in cartons containing 25 single-use, preservative-free LDPE plastic vials PF” brands and “25 vial” pack sizes.
The affected lot has been distributed to retail and online outlets across the country, so consumers should check their purchases.
What should consumers do?
Consumers who have a recalled product should stop using it immediately and return it to the place of purchase for a refund or replacement.
If you have questions or concerns, you can contact Alcon Laboratories’ Consumer Affairs team at 1-800-241-5999, Monday through Friday, 7:30 a.m. to 6:00 p.m. CST problems with this product should contact their healthcare provider immediately.
Distributor and Retail Operations
Alcon notified distributors and retailers immediately by letter, e-mail or phone, and instructed them to discard any remaining stock of the affected lot to prevent further distribution.
FDA Notification and Adverse Event Reporting
The US Food and Drug Administration (FDA) has been notified of this recall. Consumers or healthcare providers who experience adverse reactions or quality problems with the product are encouraged to report them to the FDA’s MedWatch Adverse Event Reporting Program.
Reports can be submitted online, or forms can be requested by calling 1-800-332-1088. Completed forms can be mailed to the address on the form or faxed to 1-800-FDA-0178.
Security Commitment
Alcon Laboratories emphasizes its commitment to consumer safety and product quality, and said in a statement that it is working diligently to have all affected products recalled and replaced.
This recall emphasizes the importance of vigilance in product safety, especially for medical products intended for sensitive areas such as the eyes.
RELATED CONTENT: FTC cracks down on Lyft for deceptive revenue claims
