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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.

  1. Implement appropriate impact resistance testing procedures based on lens type
  2. Establish batch definition and statistical sampling plans for applicable lens types
  3. Maintain required testing and distribution records for 3 years
  4. Ensure proper labeling and certification documentation
  5. Register with FDA if operating as foreign manufacturer
  6. Establish adverse event reporting procedures if operating as importer
  7. Implement quality system controls for lens manufacturing processes
  8. Train staff on proper testing procedures and documentation requirements
  9. Verify compliance with import requirements if applicable
  10. 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
  • 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

  • Impact-Resistant Lenses in Eyeglasses and Sunglasses: Testing, Documentation, and Import Requirements
  • HTML / PDF
  • Issue date: 2010-09-02
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 024f85afbe5f3597d898512df19dd8e7
This post is licensed under CC BY 4.0 by the author.