The referral comes following an increase in eye injuries.
The FDA has released draft guidelines for the labeling of hydrogen peroxide contact lens care products intended to prevent misuse that could lead to serious eye injury.1 The guidelines are the result of an increase in the number of adverse events reported to the agency, including eye irritation, severe stinging or burning, and blindness. Many reports have noted that it is not easy to distinguish hydrogen peroxide-based contact lens care products from products that do not pose the same potential risk of serious injury.
In addition to the general advice that labels should not exceed an eighth grade reading level, labels should answer 4 important questions:
- How does the product work?
- What is the correct use of the product?
- What are the risks of the product?
- Who to contact in case of a problem ?
Adverse events, as well as risks and benefits, should be stated in a balanced manner using layman’s language. Performance claims that are misleading or unsubstantiated should not appear on the packaging. These current guidelines will supersede the recommendations made in the 2010 Guidelines for the Labeling of Contact Lens Products Containing Hydrogen Peroxide Contact Lens Care Products.
Recommended warnings and advice that should be present include use only where intended, a warning that unneutralized disinfectant solution should not be placed in the eye, what to do if unneutralized solution enters in contact with the eye and strong warnings against reusing the neutralizing solution. solution, rinse contact lens with hydrogen peroxide care label and put hydrogen peroxide contact lens care solution into eyes.
Comments are welcome through October 17, 2022 on regulation.gov in filing #FDA-2022-D-0986-0001.
Reference
- Hydrogen Peroxide Contact Lens Care Products: Consumer Labeling Recommendations – Premarket (510(k)) Notification Submissions. Orientation project. FDA. Posted August 17, 2022. Posted August 23, 2022.
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