The guidance comes as a result of an increase in eye injury.

The FOOD AND DRUG ADMINISTRATION has released draft guidance for labeling hydrogen peroxide-based contact lens care products meant to prevent misuse that may result in serious injury to eyes. 1 The guidance is a result of an increase in adverse event reporting to the agency, including eye irritation, severe stinging or burning, and blindness. Many reports noted that it was not easy to distinguish hydrogen peroxide-based lens care products from items that don’t have the same potential risk for severe injury.

In addition to the general assistance that labels should be not exceed a good eighth-grade reading level, labeling should address 4 important questions:

  • How does the product work?
  • What is the correct use for the product?
  • What are the product’s risks?
  • Who must be contacted if a problem occurs?

Adverse events, as well as risks and benefits, ought to be indicated in a balanced way using lay language. Statements about performance that are either misleading or unsubstantiated should not be made on packaging. This current guidance will supersede the particular recommendations produced in 2010 guidance upon labeling regarding contact lens products with hydrogen peroxide-based contact lens care products.

Recommended warnings and guidance that should be present include only using within provided cases, a warning that unneutralized disinfecting solution should not really be placed into the eye, what to do if unneutralized solution arrives in get in touch with the eye, plus strong alerts against the reuse of the neutralizing solution, rinsing the contact lens with labeling hydrogen peroxide-based treatment, and putting the hydrogen peroxide-based lens care answer into eye.

Comment will be welcome until October 17, 2022 at regulations. gov in docket #FDA-2022-D-0986-0001.

Reference

  1. Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations — Premarket Notification (510(k)) Submissions. Draft Guidance. FDA. Issued August seventeen, 2022. Published August 23, 2022.

Leave a Reply

Your email address will not be published.