China Ophthalmic Innovative Medical Devices Report 2023: Three Breakthrough Products Approved by NMPA

Personalized Customization:By designing and selecting materials for intraocular lenses and rigid contact lenses, the needs of different patients are met, improving visual quality and wearing comfort.

Advancements in Vision Correction Technology:By extending the depth of focus and employing wavefront shaping technology, more precise vision correction is achieved, reducing patients' dependence on glasses.

Product Diversification:Develop more types ofIntraocular Lens and RigidContact Lens for Sexual ContactProducts, providing more options for clinical treatment.

EyeFutureThe following is a summary and review of these three products and their respective companies (with related reports attached):

1. Alcon: Intraocular Lenses (Two Models)

Product 1 Overview:

Product Name: Intraocular Lens

Manufacturer: Alcon Laboratories, Inc. (USA)

Approval Date: 2023/4/17

China Medical Device Registration: 20233160146

This product is a one-piece posterior chamber intraocular lens that uses patented wavefront shaping technology to make fuller use of the light entering the eye, while also expected to reduce the common side effects of halo and/or other visual disturbances associated with diffractive intraocular lenses.

This product is suitable for adult patients with preoperative corneal astigmatism <1.00D who have undergone extracapsular cataract extraction and are left aphakic, where a primary intraocular lens implantation is performed for vision correction. The product mitigates the impact of presbyopia on the patient's near, intermediate, and far vision by extending the depth of focus. While maintaining adequate distance vision, it expands the range of vision from far to functional near distances, reducing the patient’s reliance on glasses. The availability of this product will provide patients with a new treatment option.

Product 2 Overview:

Product Name: Intraocular Lens

Manufacturer: Alcon Laboratories, Inc. (USA)

Approval Date: 2023/7/20

China Medical Device Registration: 20233160317

This product is a one-piece posterior chamber intraocular lens, with its anterior surface center featuring a wavefront shaping structure based on patented technology. It is suitable for adult patients with corneal astigmatism who have undergone extracapsular cataract extraction, and it is implanted in a single procedure to correct vision by extending the depth of focus—expanding the range of vision from far to functional near while maintaining adequate distance vision, thereby reducing patients' reliance on glasses. The availability of this product will provide more options for clinical treatment.

Company Introduction:

Alcon (Alcon, NYSE:ALC) is the world's largest professional company in ophthalmic pharmaceuticals and medical devices with a history of over 75 years. It mainly engages in the research, development, production, and marketing of ophthalmic medicines, ophthalmic surgical equipment, and contact lens-related care products. Alcon has the most extensive range of eye care products in the field, with its product lines divided into two categories: surgical business and vision care business.

Just Now! Three Innovative Medical Devices Approved for Marketing

2. Vision Xlab: Rigid Scleral Contact Lens

Product Overview:

Product Name: Rigid Scleral Contact Lens

Manufacturer: Vision Xlab

Approval Date: 2023/8/3

NMPA Registration: 20233161081

This product is a daily wear rigid scleral contact lens, a type of large-diameter rigid contact lens (commonly known as "scleral lens"), made of fluorosilicone acrylate (hexafocon A) and tinted ice blue. The product consists of four arc segments: the optical zone (OZ), mid-peripheral zone (PCCZ), limbal zone (LCZ), and scleral landing zone (SLZ). During clinical fitting, adjustments to the parameters of each arc segment allow for an ideal tear layer thickness under the lens, improving visual quality while also protecting the corneal tissue. This product innovatively adopts a dual-sagittal depth asymmetrical design, which better accommodates asymmetrical sclerae. The scleral landing zone features a reverse curve design, providing a more comfortable wearing experience for patients.

This product is suitable for correcting irregular astigmatism, or for patients with refractive errors who also have regular corneal astigmatism of less than 5.00D and a range of +25.00D to -25.00D. The launch of this product will provide more options for clinical treatment.

Company Introduction:

Vision Xlab is a wholly-owned subsidiary of Vision Xlab (Guangdong) Medical Technology Co., Ltd. Vision Xlab is dedicated to the research, development, and production of comprehensive solutions for ophthalmic medical devices in the field of optometry. With innovation at its core, the company addresses clinical needs in optometry and ocular surface health. It has made significant advancements in key areas such as vision correction, ocular surface health, and myopia prevention and control in adolescents. Its product range includes rigid contact lenses, soft contact lenses, ophthalmic diagnostic equipment, and eye care products, offering a one-stop, advantageous portfolio covering optometric diagnosis, treatment, care, and health management.

Only in China! Rigid Scleral Contact Lens Approved for Marketing