| Product Name | Soft (Hydrophilic) Contact Lenses |
| Classification | Class III |
| Review Division | Center for Medical Device Evaluation of NMPA |
| Applicant Name | CooperVision Inc. |
| Registration Pathway | Imported Device Priority Review Pathway |
| Product Description | The product is a daily wear soft hydrophilic contact lens. The lenses which are made of omafilcon A are blue and packed in polypropylene cups. The lens adopts concentric bifocal design with 60% of nominal water content. The recommended replacement period is one day. The product is sterilized by moist heat, and the shelf-life is seven years. |
| Indications for Use | This product is suitable for people with initial wearing age of 8-12 years, diopter of -0.75d ~ -4.00d and astigmatism of no more than 0.75D, and people who have no eye diseases but phakic eye to correct myopia. The product has concentric bifocal design. The light in some optical areas can be focused in front of the retina to form myopic defocus, so as to delay the change of eye axis length of patients. The product shall be checked and matched by ophthalmologists with intermediate professional title or above in medical institutions, and rechecked regularly. |
| Summary of Non-Clinical Testing | The applicant submitted the following non-clinical research materials: · Product performance research · Biocompatibility · Sterilization · Product shelf-life and packaging Contact us to learn more about how to prepare the non-clinical study of this type of product |
| Summary of Clinical Evaluation | · Clinical pathway: clinical trial · Clinical design: prospective multicenter, double-blind, parallel control · Site number: 4 sites · Sample size: 144 subjects, of whom 108 completed 3-year follow-up. Contact us to learn more about the clinical evaluation of this type of product |
| Product Risk/Benefit Analysis | This product can help suitable crowd to correct myopia. But some risks may resulted form the use of it, including: · Increase the risk of keratoconjunctival lesions, and even develop eye infections such as keratitis and corneal ulcers; · Even if this product is used correctly, there may still be pathological changes such as corneal endothelial cell reduction and corneal neovascularization due to individual differences; · Daily contact lenses cannot be worn for sleep. Otherwise, it will increase the risk of serious adverse events; · Compared with conventional soft hydrophilic contact lens products, the smaller optical area of the product may have an impact on children’s outdoor activities, and the smaller field of vision, affecting outdoor activities in night time and low light intensity environment; · The myopia defocus effect produced by the concentric bifocal design of the product may cause relevant risks due to eye discomfort at the initial stage of wearing. In order to ensure the safety of the use of machinery, it is necessary to include the following information in the IFU: · Warnings and precautions · Contraindications · Others Contact us to learn more about the risk/benefit analysis of this type of product |
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