There is a long history of contact lens legislation and innovation.
While innovation has allowed us to create improving contact lens wearing experiences for our patients, our ability to prescribe lenses safely and effectively is continually shaped by legislative changes. Legislation has also played a major role in protecting the health of our patients.
The following infographic will highlight the history of contact lens legislation and some important milestones of innovation along the way.
Timeline of Events:1-10
1508 - First illustration of the concept of contact lenses is introduced by Leonardo da Vinci
1823 - Lens design is conceptualized by British astronomer Sir John Herschel
1887 - The first contact lens is manufactured from glass, and fitted to cover the entire eye
1940 - Contact lenses are made with plastic rather than blown-glass for the first time
1950 - Lenses are re-designed to cover only the cornea, drastically improving comfort and oxygen permeability.
1971 - Introduction of soft contact lenses
1976 -Contact lenses are first classified as a Class III medical device regulated by the U.S. Food and Drug Administration (FDA)
1978 - Introduction of Gas Permeable contact lenses
1981 - FDA approves soft contact lenses for overnight (extended) wear
1988 - ACUVUE® introduces the first disposable contact lenses
1992 - United States Congress passed the Safe Medical Device Act, the requirement for FDA to reclassify daily wear use of contact lenses as Class II medical devices.
1993 - ACUVUE® launches very first single use daily disposable contact lenses
2002 - Silicone-hydrogel contact lenses first marketed
2003 - Fairness to Contact Lens Consumers Act Signed into Law1
2005 - Acuvue Oasys® Brand Contact Lenses with HYDRACLEAR™ Plus Technology introduced
2007 - ACUVUE® Introduces first silicone hydrogel lenses with BLINK STABILIZED™ Design - ACUVUE® OASYS® Brand Contact Lenses for ASTIGMATISM
2010: Custom-manufactured silicone-hydrogel lenses become available
2010: ACUVUE® Introduces the world's first silicone hydrogel daily disposable contact lenses
2013: Unilateral Pricing Policy first utilized with contact lenses2
2015: ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraLuxe® Technology launched
2015: 1-DAY ACUVUE® MOIST Brand MULTIFOCAL Contact Lenses launched
2015: The Coalition for Patient Vision Care Safety forms3
2016: ACUVUE® VITA™ Brand Contact Lenses with HydraMax™ Technology Released
2016: The Coalition for Contact Lens Consumer Choice forms4
2016: Contact Lens Consumer Health Protection Act (CLCHPA) introduced5
2016: FTC proposes changes to the Contact Lens Rule6
1. Fairness to Contact Lens Consumers Act (FCLCA)
The Fairness to Contact Lens Consumers Act (FCLCA) became law on February 4, 2004. This Act mandates that all eyecare providers release contact lenses prescriptions to their patients, and requires sellers to verify the validity of contact lens prescriptions before releasing contact lenses to consumers.
The premise of this law, was to assure all patients received a copy of their prescription prior to choosing to purchase contact lenses from their eyecare provider even in the absence of request.
"FCLCA Compliance and Contact Lens Safety." FCLCA Compliance and Contact Lens Safety. American Optometric Association, 2016. Web. 02 Nov. 2016.
2. Unilateral Pricing Policy First Utilized in the Contact Lens Industry
UPP, or “unilateral pricing policy,” was first utilized in the contact lens industry 2013. This policy established a minimum price that retailers could sell certain contact lenses for. The policy was adopted by nearly every major contact lens company: Alcon, Bausch+Lomb, CooperVision, and Johnson & Johnson Vision Care, Inc., throughout 2014.
3. The Coalition for Patient Vision Care Safety
The Coalition for Patient Vision Care Safety is comprised of healthcare providers, medical device makers, and patient advocacy and health research organizations who wish to ensure safe access to contact lenses through emphasis on regular eye exams, and proper contact lens selection, care, and safety.
The goal of this organization centers on modernizing the Fairness to Contact Lens Consumers Act while maintaining consumer choice, by supporting a modification to the passive verification process, strengthening enforcement, and limiting quantities of lenses available to patients nearing the expiration date of the prescription.
"About the Coalition." Coalition for Patient Vision Care Safety. N.p., n.d. Web. 28 Nov. 2016.
"Advocating for Patient Safety: the Coalition for Patient Vision Care Safety Commends Legislation Designed to Enhance Prescription Verification Standards."Brownstein Hyatt Farber Schreck, LLP, 09 Sep. 2016.
4. The Coalition for Contact Lens Consumer Choice
The Coalition for Contact Lens Consumer Choice is comprised of several major retailers who seek to challenge the way contact lenses are prescribed. Their goal is to deregulate contact lenses.
“Contact lens consumers should be able to buy their lenses at affordable prices wherever and whenever they wish, whether online, over-the-phone or in a store...”
Brian Bethers, Chief Executive Officer of 1-800 Contacts
"Retailers Launch Coalition to Press for Contact Lens Deregulation." Vision Monday, 20 Apr. 2016. Web. 28 Apr. 2016.
5. Contact Lens Consumer Health Protection Act (CLCHPA)
The CLCHPA was introduced by Senators Cassidy and Boozman in April 2016 followed by a House companion bill in September 2016 and highlights the efforts to support patients’ eye health, safety, and access to lenses. This legislation raises awareness to issues such as the passive verification process defined within the Fairness to Contact Lens Consumers Act.
"Johnson & Johnson Vision Care's Federal and State Advocacy Efforts." An Overview of Johnson & Johnson Vision Care's Federal Efforts to Promote Healthy Vision and Safe Use. Johnson & Johnson Vision Care, Inc, 2016. Web. 02 Nov. 2016.
6. Federal Trade Commission Proposes Changes to the Contact Lens Rule
If finalized, this proposal would require contact lens prescribers to obtain a patient's signed acknowledgment of a document that must state:
My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting, and; I understand I am free to purchase contact lenses from the seller of my choice.
Prescribers would be required to keep a copy of this signed acknowledgement for 3 years.
"FTC Seeks Comment on Proposed Changes to Contact Lens Rule." FTC Seeks Comment on Proposed Changes to Contact Lens Rule | Federal Trade Commission. Federal Trade Commission, 2016. Web. 28 Nov. 2016.
Important Next Steps
In addition to this amendment, the FTC is soliciting comment on three additional provisions:
- Additional Mechanisms for Improving Prescription Portability;
- Additional Copies of Prescriptions; and
- Sellers Designated to Act on Behalf of Patients.
There is one more step in the rulemaking process: the FTC is seeking public comment on its proposals.
As providers that understand the implication of the proposed changes to both patients and practices it is critical that eyecare professionals voice their thoughts. We must comment on said proposals on or before January 30th, 2017, and can do so by following this link.
Meaningful change can only occur if the FTC hears from a large number of providers on these important proposals.
“FTC Proposes Changes to the Contact Lens Rule.” Johnson & Johnson Vision Care, Inc., 11 Nov. 2016. Web. <http://www.jnjvisioncareinfo.com/>
Additional Sources:
- Heiting, OD Gary. “When Were Contact Lenses Invented?” All About Vision. AAV Media, LLC, Aug. 2016. Web. 14 Dec. 2016.
8. A History of Contact Lens Innovation HOW MANUFACTURERS HAVE CHANGED THE WAY WE SEE. Digital image. Johnson & Johnson Vision Care, Inc, 2015. Web. Dec. 2016.
- Bringing Healthy Vision to Everyone, Every Day CONTACT LENSES & MEDICAL DEVICES – FDA CLASSIFICATION. Digital image. Johnson & Johnson Vision Care, Inc, 2015. Web. Dec. 2016.
10. Strong Record of Product Innovation Based on EYE-INSPIRED® Design. Digital image. Johnson & Johnson Vision Care, Inc, 2016. Web. Dec. 2016.
Important Safety Information
ACUVUE® Brand Contact Lenses are indicated for vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available by visiting acuvueprofessional.com or by calling 1-800-843-2020.
