Scope Health Faces Class Action Over OPTASE® Eye Drops and FDA Violations

Case Overview: A class action lawsuit claims Scope Health sold unapproved OPTASE eye drops, violating federal drug safety laws.

Consumers Affected: U.S. buyers of OPTASE products marketed or sold without FDA approval.

Court: U.S. District Court for the Eastern District of New York

Scope Health, Inc. sold a line of popular eye products, including OPTASE® Dry Eye Intense Drops, without securing approval from federal regulators putting consumers at risk, a new lawsuit claims.

The complaint accuses the company of violating the Food, Drug, and Cosmetic Act by marketing unapproved drugs, misbranding them, and failing to comply with manufacturing standards. 

The lawsuit follows a July 2025 warning letter from the Food and Drug Administration, which flagged multiple Scope products for unlawful marketing. 

Plaintiff Says OPTASE Eye Drops Were Sold Without FDA Approval

The lawsuit is led by Staten Island resident William Noonan, who purchased OPTASE® Dry Eye Intense Drops earlier this year from a local pharmacy. According to the complaint, Noonan and others paid full price for products that were, in reality, unlawful to sell. 

He says he and other consumers were misled into believing the drops were safe and compliant with federal standards, when in fact they contained unapproved active ingredients such as sodium hyaluronate and trehalose.

The lawsuit claims buyers like Noonan unknowingly handed over money for products that should never have been on store shelves in the first place. It argues that Scope profited unjustly and should be required to return those funds.

Lawsuit Claims Scope Marketed Unapproved Drugs as Safe Treatments

At issue are four products promoted as treatments for dry eye and other conditions: OPTASE® Dry Eye Intense Drops, OPTASE® Hylo Night Ointment, OPTASE® Protect, and OPTASE® Moist Heat Mask (when sold with drug claims). 

None, the FDA said, are backed by an approved application or considered generally recognized as safe and effective.

The lawsuit argues that Scope used marketing to present its products as therapeutic solutions for moderate to severe dry eye and related conditions, which legally classifies them as drugs. 

Without FDA approval, the products are considered both misbranded and unlawful to sell. The lawsuit contends that Scope had a duty to sell only compliant products and failed to do so, leaving consumers stuck with items of diminished value.

Other Eye Product Lawsuits Highlight Growing Safety Concerns

Scope isn’t the only company in the spotlight. EzriCare LLC has faced multiple class action lawsuits after the FDA found its artificial tears were contaminated with bacteria, leading to reports of severe infections, blindness, and even death. Alcon Laboratories was recently sued after fungal contamination was discovered inside sealed vials of its Systane Lubricant Eye Drops. 

And in the cosmetics world, Elixir Cosmetics is defending a lawsuit alleging its Babe Lash and Babe Brow serums contained a hidden prescription-grade ingredient linked to glaucoma drugs.

In his lawsuit, Noonan is asking to represent all U.S. consumers who bought the recalled Scope eye products. The complaint seeks damages, fees, and interest, while also demanding the company be held accountable for negligence and unjust enrichment. 

Case Details

• Lawsuit: Noonan v. Scope Health, Inc. 
• Case Number: 1:25-cv-04997 
• Court: U.S. District Court for the Eastern District of New York

Plaintiffs' Attorney:

• Philip J. Furia (Furia Law, LLC)

Have you used any of Scope’s OPTASE eye products? Did you trust they were FDA-approved? Tell us what you think in the comments.