The Sjögren’s Foundation remains dedicated to the safety of Sjögren’s patients and providing you with the information you need to make important health decisions.
On December 23, 2024, the FDA issued a voluntary recall on one lot (Lot 10101) of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count. The parent company, Alcon Laboratories, evaluated a complaint of a foreign substance and determined it to be fungal contamination.
Fungal contamination can potentially cause eye infections and may be vision-threatening or in very rare cases potentially life-threatening in immunocompromised patients (those that take drugs to suppress the immune system).
To date, Alcon Laboratories has not received any reports of adverse events related to this recall.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The Sjögren’s Foundation remains dedicated to the safety of Sjögren’s patients and providing you with the information you need to make important health decisions.
On December 23, 2024, the FDA issued a voluntary recall on one lot (Lot 10101) of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count. The parent company, Alcon Laboratories, evaluated a complaint of a foreign substance and determined it to be fungal contamination.
Fungal contamination can potentially cause eye infections and may be vision-threatening or in very rare cases potentially life-threatening in immunocompromised patients (those that take drugs to suppress the immune system).
To date, Alcon Laboratories has not received any reports of adverse events related to this recall.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.