Contact Lens Care Product Labeling: Warnings, Instructions and Readability Requirements
This guidance is an addendum focusing on strengthening warnings and directions for use labeling of contact lens care products, including solutions, lens cases, and accessories. It applies to both rigid gas permeable and soft (hydrophilic) contact lens care products classified as Class II devices.
What You Need to Know? 👇
What are the key labeling requirements for contact lens care products under FDA guidance?
Contact lens care products must include patient labeling with clear instructions for use, warnings, and precautions written at an eighth-grade reading level. The labeling should emphasize “rub and rinse” cleaning regimens, proper lens case care, and specific warnings about water exposure and solution reuse.
Should contact lens solutions still be labeled as “no-rub” products?
No, the FDA recommends removing “no-rub” claims from product labeling. Evidence shows that “rub-and-rinse” regimens provide greater microbial reduction. All multi-purpose solutions should emphasize the importance of rubbing and rinsing lenses for proper disinfection and safety.
What specific warnings must be included about lens case care and solution reuse?
Labeling must warn against reusing or “topping off” old solution, as this reduces disinfection effectiveness and can lead to severe infection, vision loss, or blindness. Instructions should specify using only fresh solution, proper case cleaning with sterile solution, and regular case replacement.
How should manufacturers address water exposure risks in contact lens labeling?
Labeling must warn that water can harbor microorganisms leading to severe infection, vision loss, or blindness. Users should be instructed to discard lenses exposed to water (swimming, showering) and replace with new pairs. Clear warnings about never using water for lens care are required.
What are the classification requirements for rigid gas permeable and soft contact lens care products?
Both rigid gas permeable (21 CFR 886.5918) and soft contact lens care products (21 CFR 886.5928) are classified as Class II medical devices with special controls. They require 510(k) premarket notification and must follow specific guidance documents for labeling and safety requirements.
How should multi-purpose contact lens solutions be properly labeled according to FDA guidance?
Multi-purpose solutions should only be labeled for cleaning, disinfecting, storing, and rinsing functions. They should not be labeled as “ALL-IN-ONE” solutions since they don’t include lubricating/rewetting or enzyme treatment functions. Clear distinction from other lens care products is required.
What You Need to Do 👇
Recommended Actions
- Review and update product labeling to include enhanced warnings and instructions
- Implement “rub and rinse” directions and remove “no-rub” claims
- Add specific warnings about solution reuse, water exposure, and lens case care
- Format warnings and instructions to improve readability
- Include discard date information on product packaging
- Ensure labeling meets eighth grade reading comprehension level
- Consider adding visual aids (like infection photos) with appropriate context
- Update website content to include patient labeling information
- Develop communication strategy for eye care professionals about labeling updates
- Ensure all labeling claims are supported by pre-clinical testing data
Key Considerations
Non-clinical testing
- Pre-clinical microbiology testing should support the labeled rubbing and rinsing times
Human Factors
- Patient information labeling should not exceed eighth grade reading comprehension level
- Labeling should be easily readable and formatted to enhance readability
- Consider reasonable rinse times that promote user compliance
Labelling
- Include a glossary after table of contents
- Remove “no-rub” from product labeling and emphasize “rubbing and rinsing”
- Include specific warnings for:
- Solution reuse/”topping off”
- Water exposure
- Lens case care
- Discard dates
- Include instructions for bringing lenses, solutions, and case to eye care provider if infection occurs
- Multi-purpose products should only be labeled for cleaning, disinfecting, storing and rinsing
- Include fill-in space for “date opened or discard date” on bottle label
Safety
- Emphasize risks and complications associated with improper use
- Include specific warnings about water exposure and contamination risks
- Provide clear instructions for lens case cleaning and replacement
Other considerations
- Consider placing patient labeling on manufacturer’s website
- Recommend eye care professionals review labeling with patients
Relevant Guidances đź”—
- Design Controls for Medical Device Manufacturers
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Device Labeling Requirements and Content for Premarket Approval Applications
- Labeling Requirements and Recommendations for Medical Devices
Related references and norms đź“‚
- 21 CFR 820.30: Quality System Regulation - Design Controls
- 21 CFR 886.5918: Rigid gas permeable contact lens care products
- 21 CFR 886.5928: Soft (hydrophilic) contact lens care products