Commitment to safety

Fall in Eyez (R) color contacts are made with a commitment to safety and undergo safety and quality assurance testing in accordance with the Contact Lens Approval Standards established under the provisions of Article 42, Paragraph 2 of the Pharmaceutical Affairs Act.

They are the only color contacts in Japan to have undergone clinical trials and been approved as a specially controlled medical device.

*Clinical trial: A trial by the Ministry of Health, Labour, and Welfare conducted with the purpose of verifying the safety of medical devices by having healthy people use them. Fall in Eyez(R) are the first color contacts in Japan to be worn by people, undergo a trial to verify their safety, and receive approval.

Quality control

  • In a Ministry of Health, Labour and Welfare Ministerial Ordinance on Medical Device Quality Management Systems compliance inspection regulated under Article 14, Paragraph 2, Item 4 of the Pharmaceutical Affairs Act, Fall in Eyez (R) color contact lenses were proven to conform to Japanese medical device quality assurance standards.
  • Fall in Eyez (R)color contact lenses have acquired ISO 1385 Medical Devices - Quality Management Systems and are manufactured under strict quality control.

Safety

  • Fall in Eyez (R) color contacts undergo safety and quality assurance testing in accordance with the Contact Lens Approval Standards established under the provisions of Article 42, Paragraph 2 of the Pharmaceutical Affairs Act. They have had their safety verified; they are the first color contact lenses in Japan to undergo clinical trials and have also undergone physical, biological, and chemical testing.
  • Fall in Eyez (R)color contact lenses have had their safety as a product evaluated and have received CE marking, established as a requirement of safety and quality that must be fulfilled when distributing a product in the markets of the European Union.

Lens construction

Fall in Eyez (R) uses sandwich construction for all our contacts, so the color layer never comes into direct contact with the eye.

Results of safety testing

The results of our safety and quality assurance testing in accordance with the Contact Lens Approval Standards established under the provisions of Article 42, Paragraph 2 of the Pharmaceutical Affairs Act are as follows.

Physical requirements
1 Shape and appearance   Pass
2 Diameter Within ±0.20 mm Pass
3 Thickness Within ±0.01 Pass
4 Interior radius of curvature Within ±0.20 mm Pass
5 Vertex power Within ±0.25D Pass
6 Visual transmittance ±5% (absolute value) Pass
7 Oxygen permeability Within ±20% Pass
8 Refractive index Within ±0.005 Pass
9 Moisture content Within ±5% (absolute value) Pass
10 Prism correction Within ±0.25cm/m Pass
Chemical requirements

No abnormalities in results of all effluent material testing.

Assurance of sterility

SAL (Sterility Assurance Level): 10-6 sterility assured.

Biological requirements

We conduct our testing in accordance with GLP (Good Laboratory Practice: standards for the safety of animal testing).

1 Cytotoxicity test No cytotoxicity indicated.
2 Extractability test No deformation or dissolution of extraction solvents found.
3 Eye irritation test Found to cause no irritation to ocular tissue (cornea, iris, conjunctiva, or lens).
4 Wearability test Found to have no influence on ocular tissue (cornea, iris, conjunctiva, or lens).
5 Skin sensitization test Found to display no skin sensitization.
6 Reverse mutation test Found not to cause genetic mutation (negative).
7 Chromosomal aberration test Found not to cause chromosomal aberration in CHL/IU cells.
Clinical trial

Fall in Eyez(R) color contact lenses are the first in Japan to have undergone clinical trials.

Medical Equipment Manufacture and Sale Certificate of Approval

Approved as a specially controlled medical device.
Approval no.: 22300BZX00066000

Class 1 Medical Equipment Manufacture and Sale License

We have acquired the Class 1 Medical Equipment Manufacture and Sale License necessary for the manufacture and sale of contact lenses.
Class 1 Medical Equipment Manufacture and Sale License No.: 13B1X80003

Medical Equipment Manufacturing License

We have acquired the Medical Equipment Manufacturing License necessary for the manufacture of contact lenses.
Medical Equipment Manufacturing License No.: 13BZ200397

Medical Equipment Manufacturing License

We have acquired the Medical Equipment Manufacturing License necessary for the manufacture of contact lenses.
Medical Equipment Manufacturing License No.: 13BZ200660

Specially Controlled Medical Devices Sale License

We have acquired the Specially Controlled Medical Equipment Manufacture and Sale License necessary for the manufacture and sale of contact lenses.
Specially Controlled Medical Devices Sale License No.: 4501030600004

Specially Controlled Medical Devices Sale License

We have acquired the Specially Controlled Medical Devices Sale License necessary for the sale of contact lenses.
Specially Controlled Medical Devices Sale License No.: 0204

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