Eye drops recalled because of possible fungal contamination that could affect vision: FDA warns

The US Food and Drug Administration (FDA) has raised the alarm over a nationwide recall of Systane brand eye drops, citing a potential fungal contamination that could pose a serious risk to vision.

Systane Lubricant Eye Drops Ultra PF, commonly used to temporarily relieve burning and irritation caused by dry eye symptoms, is currently the subject of a nationwide recall. The product was distributed to multiple retail stores and online platforms.

Manufacturer Alcon Laboratories initiated a voluntary recall after a consumer reported a foreign body in a unopened single-use vial that was later identified as fungal contamination.

“Fungal contamination of an ophthalmic product is known to have the potential to cause eye infections. If infection occurs, it may be vision-threatening and, in very rare cases, potentially life-threatening in immunocompromised patients,” the FDA said in its statement. press release.

The FDA confirmed that no adverse events related to the drug recall have been reported to date. However, people who experience quality issues or adverse reactions after using the product are encouraged to report them through the FDA’s MedWatch Adverse Event Reporting program. You can submit complaints on the Internetby downloading and sending the file formor fax 1-800-FDA-0178.

Each carton of the product contains 25 sterile, single-use vials of lubricant solution for ophthalmic use. “Product specific Systane Lubricant Eye Drops Ultra PF, single vials for travel use, quantity 25 is limited to lot number 10101, expiry date 2025/09. The product can be recognized by the green and pink carton packaging design and the presence of “Systane” and “ULTRA PF” brand names on the front of the box and the package size of “25 vials,” the press release reads.

Consumers who still have the products are advised to stop using them immediately and return to the place of purchase for an exchange or refund. People who experience any problems potentially related to the use of these eye drops should seek medical advice immediately.

An Alcon spokesman is investigating he said NBC News reports that “the presence of foreign materials appears to be related to a single unit returned by a customer.” They stressed that the recall is being done “out of an abundance of caution to prioritize consumer safety.” People who have issues with the product can also contact them at 800-241-5999.