On August 17, 2022, the FDA issued the draft guidance: Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions.
This draft guidance provides labeling recommendations for hydrogen peroxide-based contact lens care products. These labeling recommendations are intended to promote the safe and effective use of these contact lens care products and ensure that consumers receive and understand information regarding the benefits and risks associated with the use of the device.
Submit comments under docket number FDA-2022-D-0986 at https://www.regulations.gov/ by October 17, 2022.
Hydrogen peroxide and multipurpose solutions both clean and disinfect contact lenses by breaking up and removing trapped debris, protein, and fatty deposits (lipids). Unlike multipurpose solutions, hydrogen peroxide solutions are preservative-free, which makes them a suitable option for those who are allergic or sensitive to the preservatives found in multipurpose solutions. They are not risk-free, however, and should be used with appropriate cautions.
How to use Hydrogen Peroxide correctly
Hydrogen peroxide placed directly into the eyes or on your contact lenses can cause stinging, burning, and temporary corneal damage. When using hydrogen peroxide you must follow the disinfecting process with a neutralizer. The neutralizer turns the peroxide into water and oxygen, making it safe to put your lenses back into your eyes.
Neutralization can be either a one-step or two-step process. The one-step process neutralizes your lenses during the disinfecting stage, while the two-step process neutralizes your lenses after the disinfecting stage.
Some storage cases have a neutralizer built-in, making it a simple one-step process. With other cases, a neutralizing tablet that comes with the hydrogen peroxide solution must be added. This is the two-step process.
Always consult your eye-care provider before deciding on the best cleaning and disinfecting method for your lenses. Never change your lens-care system before consulting your eye care provider.
Tips for Using Hydrogen Peroxide Contact Lens Solutions Safely
- Before you use a new contact lens solution, READ ALL THE INSTRUCTIONS LISTED ON THE BOX AND BOTTLE AND FOLLOW THEM CAREFULLY.
- Be sure to use the special contact lens case that comes with your hydrogen peroxide contact lens solution. NEVER use any case other than the one that comes with every new bottle. Do NOT use the old case when you get a new bottle of peroxide based contact lens solution. If you do, it will not neutralize the peroxide and it will cause burning, stinging and irritation when you put your contacts in your eyes.
- Be sure to leave your contacts in the solution for at least 6 hours to allow the neutralizing process to finish.
- The red tip on the solution bottle is a reminder that these products require special handling. NEVER rinse your lenses with hydrogen peroxide solutions or put hydrogen peroxide solutions in your eyes. You will experience burning, stinging and irritation.
- DO NOT allow friends and house guests to use your hydrogen peroxide solution because they may confuse this with multipurpose solution and not use it according to the specific instructions for hydrogen peroxide solution. This could result in stinging, burning and even damage to their eyes.
Report any eye problems associated with your hydrogen peroxide solution to the FDA’s MedWatch voluntary reporting program.