Patient Labeling for Laser-Assisted In Situ Keratomileusis (LASIK) Devices (DRAFT)
This guidance provides recommendations for content and formatting of patient labeling information for LASIK devices, including a patient decision checklist. It applies to all refractive lasers with LASIK indications for use (FDA product code LZS). The guidance aims to ensure that both physicians and patients receive and understand information about the benefits and risks of LASIK devices.
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What are the key labeling requirements for LASIK devices under the new FDA draft guidance?
The FDA recommends comprehensive patient labeling including device description, indications for use, benefits/risks, contraindications, warnings, precautions, clinical study information, and a patient decision checklist. All content must be written in simple lay language and tested with representative users for comprehension.
How should manufacturers handle contraindications versus warnings in LASIK patient labeling?
Contraindications are conditions where LASIK should absolutely not be performed due to high risk of harm (severe dry eyes, insufficient corneal thickness). Warnings are conditions requiring careful evaluation where benefits may still outweigh risks (moderate dry eyes, controlled diabetes).
What specific visual symptoms must be explained to LASIK patients according to FDA recommendations?
Patient labeling must describe glare, halos, starbursts, double vision, and decreased low-light vision using clearly labeled images. The guidance emphasizes these symptoms commonly occur initially but may persist permanently in some patients, potentially affecting daily activities like night driving.
Are there special requirements for the patient decision checklist in LASIK labeling?
Yes, the checklist must be easily separable, allow for patient and physician initials/signatures acknowledging discussion of specific risks, include statistical rates of complications, and cover vision correction alternatives. It serves as confirmation that informed consent discussions occurred.
How does the FDA guidance address psychological risks associated with LASIK procedures?
The guidance acknowledges reports of severe depression and suicidality potentially linked to LASIK complications, though no definitive causal relationship is established. This must be disclosed as a potential psychological harm risk in patient labeling materials.
What testing requirements exist for LASIK patient labeling before market approval?
Manufacturers must conduct iterative usability testing with representative users to ensure comprehension of critical risk information. Testing should verify users understand risks, can make appropriate choices, and know what to expect from treatment before finalizing labeling content.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive patient labeling following the recommended format and content
- Create clear visual aids and diagrams to explain procedures and symptoms
- Develop patient decision checklist with acknowledgment sections
- Conduct usability testing with representative users
- Ensure translation of medical terms into lay language
- Include all required risk information with appropriate prominence
- Develop plan to ensure adequate patient information delivery
- Create process for documenting patient and physician acknowledgment
- Establish system for providing copies of decision checklist to patients
- Update labeling through appropriate FDA submission process (PMA supplement)
Key Considerations
Clinical testing
- Clinical study information should be described in a way meaningful to patients
- Results should use actual numbers rather than percentages
- Include purpose, objectives, study design, and key safety/effectiveness outcomes
- Include contrast sensitivity testing outcomes
Human Factors
- Patient labeling should be tested with representative users in controlled situations
- Iterative testing to ensure comprehension of critical information
- Users should demonstrate adequate comprehension through recitation
Labelling
- Written in simple, lay language
- Include clearly labeled graphics
- Include patient decision checklist with acknowledgment sections
- Provide balanced presentation of benefits and risks
- Include description of eye and surgery, purpose, benefits, alternatives, risks
- Include what to expect before, during, and after surgery
- Include manufacturer and provider contact information
Safety
- Include detailed description of risks and complications
- Present most severe and frequent risks first
- Include visual symptoms with explanatory images
- Include long-term risks and complications
Other considerations
- Include considerations for good candidates
- Include information about alternatives to LASIK
- Include post-operative care instructions
- Include future eye health considerations
Relevant Guidances 🔗
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Device Labeling Requirements and Content for Premarket Approval Applications
- Writing Medical Device Patient Labeling: Content and Design Considerations
Related references and norms 📂
- IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices