December 26, 2024
Alcon has not acquired any reviews of hostile occasions associated to this recall. Nevertheless, the corporate is performing cautiously to make sure shopper security.
On Dec. 21, Alcon Laboratories issued a voluntary recall of 1 lot of its Systane Lubricant Eye Drops Extremely PF, Single Vials On-the-Go, 25-count (Lot 10101) after a shopper criticism revealed the presence of overseas materials later recognized as fungal.
The recalled product, generally used to quickly relieve dry eye signs, poses a major well being threat if contaminated. Fungal contamination in ophthalmic merchandise may cause critical eye infections, which can result in imaginative and prescient loss. The infections might change into life-threatening in sporadic instances, notably in immunocompromised people.
Alcon has not acquired any reviews of hostile occasions associated to this recall. Nevertheless, the corporate is performing cautiously to make sure shopper security.
Recalled Product Particulars
The recall is proscribed to Lot 10101, which expires in September 2025. The product is packaged in cardboard cartons containing 25 single-use, preservative-free LDPE plastic vials. It may be recognized by the inexperienced and pink carton design, the “Systane” and “Extremely PF” branding on the entrance, and the “25 vials” bundle measurement.
The affected lot was distributed nationwide to retail and on-line shops, so shoppers should examine their bought merchandise.
What Customers Ought to Do
Customers who personal the recalled product ought to cease utilizing it instantly and return it to the place of buy for a refund or substitute.
You probably have questions or issues, Alcon Laboratories’ Client Relations workforce could be reached at 1-800-241-5999, Monday by Friday, 7:30 a.m. to six:00 p.m. CST. Customers experiencing hostile results or points associated to this product ought to seek the advice of their healthcare supplier instantly.
Distributor and Retailer Actions
Alcon notified distributors and retailers instantly by letter, electronic mail, or telephone. To forestall additional distribution, they had been instructed to discard any remaining inventory of the affected batch.
FDA Notification and Antagonistic Occasion Reporting
The U.S. Meals and Drug Administration (FDA) has been knowledgeable of this recall. Customers or healthcare suppliers who expertise hostile reactions or high quality issues associated to the product are inspired to report them to the FDA’s MedWatch Antagonistic Occasion Reporting program.
Stories could be submitted on-line, or types could be requested by way of telephone at 1-800-332-1088. Accomplished types could be mailed to the handle supplied on the shape or faxed to 1-800-FDA-0178.
Dedication to Security
Alcon Laboratories emphasizes its dedication to shopper security and product high quality. In a press release, the corporate assured that it’s working diligently to make sure all affected merchandise are faraway from circulation and changed.
This recall highlights the significance of vigilance in product security, particularly for medical merchandise meant for delicate areas just like the eyes. Customers are urged to take rapid motion in the event that they possess the recalled lot, to forestall potential well being dangers.
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