Product Overview
(1) Product structure and composition
The product is a one-piece, foldable, posterior chamber intraocular lens with a hydrophobic acrylate material for the body and support parts, in which a dye is added and then treated with an enhancerThe power range is 0d 34d, and the power range is 05d increments;The optical design is monofocal, aspherical, and the fold shape is L-shaped. The product is supplied sterile and is single-use. The shelf life is 5 years.
(2) Scope of application of the product
Correction of aphakic vision in adult cataract patients.
(3) Model specifications
Model: FS60A, FS57A, FS55A.
Specifications: Power 0d - 34d, to 05d is the interval.
(4) Working principle
The product is an optical lens composed of an optical body and a supporting part (fold), and its working principle is to remove the cloudy natural lens in the human eye through phacoemulsification through clinical cataract removal surgery, and then implant the product into the human eye capsule bag to replace the natural lens of the human eyeIt is based on the optical principle of the lens, which restores the patient's vision by obtaining the required focusing capacity through the optical zone.
The product uses a combination of dyes and color enhancers to regulate the blue light filtration. Dyes absorb blue light, and color enhancers enable intraocular lenses to achieve photochromic enhancement under sunlight or ultraviolet irradiation. The product is light yellow in dark environment, and dark yellow in bright environment;Back in the dark, the lens returns to a light yellow color.
Overview of preclinical studies
(1) Product performance research
1.Product Technical Requirements Study The product technical requirements research project is shown in Table 1.
Table 1 Summary of the product technical requirements research project.
2.Design verification.
The applicant carried out design verification, which included:
Optical properties: optical power, image quality, spectral transmittance, color vision impact evaluation, blue light radiation reduction, aspheric spherical aberration, color enhancement and reduction time, spectral transmittance in the color enhancement state, image quality in the color enhancement state, blue light radiation reduction in the color enhancement state.
Mechanical properties: dimensions, compressive forces, axial displacement under compressive forces, optical eccentricity, optical inclination, contact angles, compressive force attenuation, dynamic fatigue durability, surgical operations, surface and material uniformity.
Physical and chemical properties: complete extraction, leachables, hydrolysis stability, light stability, ND-YAG laser irradiation stability, residual insoluble inorganics, stability under simulated use conditions, color enhancement reaction attenuation and failure, sterility, bacterial endotoxin, ethylene oxide residue, 2-chloroethanol residue, etc.
The performance study data shows that the product meets the requirements of the design inputs.
(2) Biocompatibility
According to YY 02905 and GB T 16886 series of standards have been evaluated for biological evaluation, including: cytotoxicity test, delayed hypersensitivity test, genotoxicity, post-implantation local reaction test, intraocular implantation test, acute systemic toxicity test, subchronic systemic toxicity test. Biological risk is acceptable.
(3) Sterilization
The product is sterilized with ethylene oxide and is supplied in a sterilized state. The applicant provided an ethylene oxide sterilization confirmation report supporting the sterilization process used to achieve a sterility assurance level of 10-6.
(4) Product expiration date and packaging
The product has a shelf life of 5 years. The applicant provided a shelf life verification report, including product stability verification, packaging integrity verification, and transportation stability verification.