Systane eye drops recalled due to possible fungal contamination

The U.S. Food and Drug Administration (FDA) announced this week the voluntary recall of a lot of Systane brand eye drops due to possible fungal contamination.

The recalled drops, specifically the product Systane Lubricant Eye Drops Ultra PF Single Vials On-the-Gohad been reported by a customer who observed a “foreign material” inside a sealed vial. After a review, it was determined that the material was fungal in nature, which prompted immediate action by the authorities.

This product, commonly used to relieve dry eye symptoms, was available in individual presentations of 25 vials with lot number 10101 and an expiration date set for September 2025. Although no adverse events related to With this recall, the FDA warned that any fungal contamination in ophthalmic products represents a significant health risk. The resulting ocular infections can severely compromise vision and, even in rare cases, be life-threatening, especially in immunocompromised patients.

Alcon Laboratories, maker of Systane drops, immediately responded to the issue by assisting with the product recall and providing guidance to consumers. The company said it has not received any reports of health problems associated with the recalled batch, but stresses the importance of suspending use of any affected units.

Authorities recommended customers who own this product stop using it immediately and return it to the place where it was purchased for a replacement or refund. In addition, they urged those who have experienced any abnormal symptoms after using these drops to seek medical attention immediately.

To facilitate the query process, Alcon has set up a customer service line at 1-800-241-5999. Likewise, the FDA recalled that any adverse reaction or problem related to product quality can be reported to the MedWatch program through its online platform, mail or fax.

This incident occurs in the context of a year marked by multiple recalls of ophthalmic products. During 2023, a number of eye drops were withdrawn from the market after cases of bacterial contamination were identified, leading to serious infections and attracting public attention. Compared to those cases, where consequences included hospitalizations and close scrutiny of manufacturing practices, the recall of Systane drops appears to have been detected at an earlier stage, which could minimize risks to users.

However, this event highlights a broader issue: the need to ensure rigorous manufacturing processes and constant inspection to prevent possible contamination in products designed for ophthalmic use, where even a minimal error can have serious consequences.

The FDA reaffirmed its commitment to protecting public health by taking swift action to remove potentially dangerous products from the market. He also encouraged consumers to stay informed and proactive in reporting any anomalies in the products they use.

The recall of Systane drops is a reminder that, although rare, quality problems in medical products can occur and should be treated with the utmost seriousness.

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