The lawsuit, filed on May 14, 2026, in the U.S. District Court for the Eastern District of New York, was initiated by Bibi Khan, a consumer from Nassau County, New York. The suit alleges that Alcon:
- Marketed the products as “sterile” despite known manufacturing contamination issues.
- Failed to disclose that certain products were unsterile due to violations at the Excelvision Fareva manufacturing facility in France.
- Deceived consumers into purchasing products that had diminished value due to lack of sterility assurance.
The case is brought as a putative class action, seeking to cover all U.S. consumers who purchased the affected products within the statute of limitations period. A New York subclass is also proposed for residents who purchased the products locally.
Background: FDA Findings and Product Recall
The controversy stems from multiple inspections of the Excelvision Fareva facility:
- July 2023 & November 2024 Inspections: FDA identified mold contamination, faulty aseptic processes, and inadequate equipment cleaning.
- May 2025 Warning Letter: The FDA found Excelvision’s remediation efforts insufficient.
- January 2026 Re-Inspection: 11 new violations, six related to aseptic processing and microbiological contamination.
- April 2026 Class II Recall: Alcon voluntarily recalled all unexpired lots of Genteal Tears Lubricant Eye Gel and Systane Night Gel.
- The FDA also placed Excelvision on an Import Alert, barring entry of its drug products into the U.S. market.
When Did This Recall Occur?
- FDA Initial Warning Letter: May 2025
- Alcon Product Recall: April 2026
- Lawsuit Filed: May 14, 2026
- Products Affected: Genteal Tears Lubricant Eye Gel and Systane Night Gel Comforting Dry Eye Relief
What Information or Harm Was Involved?
While this case is a consumer class action rather than a personal data breach, the alleged harm includes:
- Purchase of products labeled as “sterile” that were potentially contaminated.
- Economic loss due to paying for products with diminished safety and efficacy.
- Risk of eye infections or serious health consequences due to contamination.
What You Can Do
Consumers who purchased the affected Alcon products should:
- Retain proof of purchase (receipts, invoices, or pharmacy records).
- Monitor for updates on the class action and court filings.
- Consider joining the class action if eligible, particularly if living in the U.S. or New York State for the subclass.
- Consult legal counsel to understand potential compensation or refunds for affected purchases.
File a Class Action Lawsuit Against Alcon Laboratories
Eligible individuals may pursue compensation through this class action lawsuit. The suit seeks redress for economic harm from misleading labeling and marketing practices. Class members may recover for overpayments, diminished product value, or related expenses.
Contact Class Action U to connect with a lawyer experienced in consumer product class actions. Our team can guide you in joining the class, filing claims, and understanding your rights. There is no cost or obligation to get started.