Contact Lens Safety & Prescription Verification

AOA Federal Priority: Safeguarding Contact Lens Patients Through Modernized Prescription Verification

Contact lenses are a safe, effective and popular choice for vision correction, with roughly 45 million Americans choosing contact lenses for their vision correction needs. But contact lenses are also medical devices that must be properly fitted and prescribed by a doctor of optometry or other eye doctor following an eye health and vision exam.

• All contact lenses, including cosmetic lenses, require a prescription from an eye doctor. Because ill-fitting or improperly used contact lenses can result in serious eye and vision complications, the U.S. Food and Drug Administration (FDA) regulates contact lenses as Class II and Class III medical devices requiring an eye doctor’s prescription and oversight.
  
  
• Improperly worn or fit contact lenses can lead to serious health complications, including infections, corneal edema and ulcers. Poor-fitting contact lenses can also contribute to corneal neovascularization, an irreversible growth of blood vessels in the eye that can result in scarring, infection, blindness and, in severe cases, removal of the eye due to persistent, uncontrollable pain.

The AOA is fighting to ensure federal law keeps pace with the realities of today’s online contact lens marketplace. Through the Fairness to Contact Lens Consumers Act (FCLCA), Congress charged the Federal Trade Commission (FTC) with enforcing contact lens prescription verification requirements. However, lax FTC enforcement of unscrupulous online sellers and continued reliance on problematic verification robocalls have contributed to illegal sales, including the filling of expired or non-existent prescriptions and the substitution of lenses other than those prescribed by the patient’s doctor.

ISSUE BRIEF    ACTION CENTER

The Case for Modernization: Why It Matters

• Patients need eye doctor oversight: The FDA and CDC make clear that contact lenses, as Class II and Class III medical devices, are not “one-size-fits-all,” and that regularly scheduled comprehensive eye exams are critical to maintaining optimal eye health.
  
  
• Improper use can cause serious harm: Ill-fitting or improperly used contact lenses can lead to infections, corneal edema, ulcers, corneal neovascularization, scarring, blindness and other severe complications.
  
  
• Online sales have increased risks: Millions of contact lens wearers now purchase lenses online through internet mass retailers, making strong prescription verification safeguards more important than ever.
  
  
• Robocalls are failing patients and doctors: Verification robocalls are often difficult to understand, may omit information needed to confirm a prescription and create barriers for doctors seeking to correct errors—including requests for the wrong devices or for individuals who are not their patients.
  
  
• Passive verification is being abused: Under the current system, if a doctor does not respond within 8 business hours, the prescription can be considered verified. Some online sellers exploit this process to sell medical devices without valid prescriptions, putting patients at needless risk.
  
  
• Expired and substituted prescriptions remain a problem: A 2016 patient survey found that 1 in 3 patients were able to purchase contact lenses using an already-expired prescription, while 1 in 4 reported receiving different medical devices than those prescribed by their eye doctor.

Legislative Action: What AOA is Doing

The AOA and the Health Care Alliance for Patient Safety (HCAPS) support the Contact Lens Prescription Verification Modernization Act, H.R. 4282, to modernize the contact lens prescription verification process and make it simpler, safer and more reliable for millions of contact lens wearers.

• The Contact Lens Prescription Verification Modernization Act would help protect patients by addressing the continued use of problematic verification robocalls and strengthening safeguards against the filling of expired, invalid or incorrect prescriptions.
  
  
• The legislation would also empower patients by ensuring online contact lens sellers offer a method for patients to upload an electronic copy of their contact lens prescription, allowing them to skip the verification process altogether when they already have a valid prescription.

The AOA is urging members of the U.S. House of Representatives to co-sponsor H.R. 4282 and help ensure contact lens patients receive only the medical devices prescribed for them by their eye doctor.

Questions? Please direct questions regarding the AOA’s federal priorities to our Federal Advocacy Team.