What Technical Files Should Be Provided If The Soft Corneal Contact Lenses Use Aspheric Optics Intended To Improve Optical Imaging?


2022-11-29

If the soft corneal contact lenses are declared to improve optical imaging, it is recommended to submit the following related technical information:

  1. Aspheric optics and its principle of operation;
  2. Complete description of the manufacturing techniques for implementing aspheric design;
  3. The validated test method and corresponding test results of the aspheric design;
  4. If it is stated in the IFU that the aspheric design of the product can improve the optical imaging effect, the research data proving the improvement in optical imaging effect should be submitted, and the corresponding performance indicators and basis for such determination should be specified.