Impact-Resistant Lenses in Eyeglasses and Sunglasses: Testing, Documentation, and Import Requirements
This guidance addresses the requirements for impact-resistant lenses in eyeglasses and sunglasses, including testing procedures, recordkeeping, and import requirements. It applies to manufacturers, importers, and testing laboratories involved in producing or distributing prescription and non-prescription lenses.
Recommended Actions
- Implement appropriate impact resistance testing procedures based on lens type
- Establish batch definition and statistical sampling plans for applicable lens types
- Maintain required testing and distribution records for 3 years
- Ensure proper labeling and certification documentation
- Register with FDA if operating as foreign manufacturer
- Establish adverse event reporting procedures if operating as importer
- Implement quality system controls for lens manufacturing processes
- Train staff on proper testing procedures and documentation requirements
- Verify compliance with import requirements if applicable
- Establish process for physician documentation when non-impact resistant lenses are prescribed
Key Considerations
Non-clinical testing
- Impact resistance testing required for all lenses using drop ball test or equivalent
- Each glass prescription lens must be individually tested
- Statistical sampling allowed for plastic lenses and non-prescription glass lenses
- Testing must be performed when manufacture and treatments are complete
- Test records must be maintained for 3 years
Labelling
- Claims of “shatterproof” or “shatter-resistant” must be truthful and not misleading
- Semi-finished lenses should be labeled “Requires further processing, not a finished device”
- Written notification required when non-impact resistant lenses are prescribed
Safety
- Impact resistant lenses required except when physician/optometrist determines otherwise
- Lenses must pass drop ball test from 50 inches height
- Base plate of testing apparatus must weigh minimum 27 pounds
- Certain specialty lenses exempt from testing but must still be impact resistant
Other considerations
- Records of sales/distribution must be maintained for 3 years
- Importers must provide certification of impact resistance
- Foreign manufacturers must register with FDA
- Adverse events must be reported by importers
Related references and norms
- ANSI/ASQC Z1.4/1993: Sampling Procedures and Tables for Inspection by Attributes
- ISO 2859-1/1999: Sampling Procedures for Inspection by Attributes
- ANSI Z87.1-1989: American National Standard Practice for Occupational and Educational Eye and Face Protection
Original guidance
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