Overview of Ophthalmic Medical Devices Approved in August 2024

Sep 29, 2024 10:07 CST Updated 10:07

Johnson & Johnson

Medical Device R&D and Manufacturer

Source: Eye Future; Editor: Sophia

Reprint Requirements: Can be reprinted 24 hours after the first publication, source must be credited.

August 2024,NMPA Approves Registration of 327 Medical Device Products。267 Class III Medical Device Products in China, 41 imported Class III medical device products, 17 imported Class II medical device products, and 2 medical device products from Hong Kong, Macao, and Taiwan.

The approved registered medical device products involve diagnostic reagents, medical equipment, orthopedics, dental materials, basic hygiene materials, medical software,Ophthalmic materials, etc.。

Among them,There are 9 products related to ophthalmic materials., including but not limited toPreloaded Toric Intraocular Lens, Soft Hydrophilic Contact Lensetc.

# 01 Johnson & Johnson Vision Care

Product Name:TECNIS Eyhance™ Preloaded Toric Intraocular Lens

Product Composition:This product is a preloaded intraocular lens, composed of an intraocular lens and an implantation system. The intraocular lens isSingle-piece posterior chamber intraocular lens, foldable, with an improved C-loop haptic design.

The main body and loops are polymerized from ethyl acrylate (EA), ethyl methacrylate (EMA), 2,2,2-trifluoroethyl methacrylate (TFEMA), ethylene glycol dimethacrylate (EGDMA), etc., with the addition of a UV absorber.Surface treated with PEG.

Range of diopters:+5.0D～+34.0D。Cylinder Power Range:1.0D～6.0D。Optical Design:Toric, aspherical, no diffraction rings, central optical power increases smoothly and continuously.

Scope of application:ProductFor the correction of aphakia and pre-existing corneal astigmatism in adult patients., the cataract lens in the patient's eye has been removed through extracapsular cataract extraction surgery. The intraocular lens can only be placed within the capsular bag.

# 02 BlessingKodama Corporation

Product Name:Soft Contact Lens

Product Composition:The product is for enhanced coloring.Daily Wear Soft Hydrophilic Contact Lenses. Polymerized from HEMA, MMA, NVP, etc., with added colorants. Packaged in vials or polypropylene boxes. Nominal water content: 40%. Recommended replacementCycle 1 month.

Scope of Application:The product is a daily wear lens,For the correction of myopia in patients without contraindications。

# 03 Aibono De (Beijing)

Product Name:Sodium Hyaluronate Eye Gel

Model and Specification:Model: HB-1; Specifications: 0.5mL, 0.8mL, 1.0mL, 1.5mL, 2.0mL, 2.25mL.

Product Composition:The product isA gel-like solution formulated with sodium hyaluronate prepared by microbial fermentation., filled in pre-filled syringes sterilized with ethylene oxide, then sterilized with high-pressure steam, and paired with a disposable sterile flushing needle. The product has a sodium hyaluronate concentration of 20mg/mL.

Scope of application:Used as a filler in ophthalmic surgery, serving as a surgical space maintainer and surgical pad.Ophthalmic surgery includes: cataract extraction and intraocular lens implantation.

# 04 Gao Shi Tai Liang

Product Name:Aspheric Intraocular Lens

Product Composition:Aspheric intraocular lens isOne-Piece Posterior Chamber Intraocular Lens, foldable, with a plate-type haptic, the main body and haptic are made of the same material, composed of copolymers such as 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate, with added UV absorber;Optical Design;Single-focus, Aspherical(The axial section diopter distribution within a 1.5mm radius of the aperture conforms to the characteristics of zero spherical aberration distribution under simulated eye conditions).

Scope of Application:Aspheric intraocular lenses are used forPrimary implantation for vision correction in aphakic eye patients, to restore vision for cataract patients.

# 05 Jilin Ruierkang Optical Technology

Product Name:Soft Hydrophilic Contact Lenses

Product Composition:The product is for enhanced coloring.Daily Wear Soft Hydrophilic Contact Lenses.Composed of HEMA, MMA, NVP and other polymers, with added colorants, packaged in polypropylene boxes. Nominal water content: 42%. Recommended replacement cycle is 1 month.

Scope of application:Product is suitable forCorrection of Myopia in Patients Without Contraindications。

# 06 Jiangsu Duoz Medical Technology

Product Name:Soft Hydrophilic Contact Lenses

ProductComposition:Product for Enhanced ColoringDaily Wear Soft Hydrophilic Contact LensesThe lens material is polymerized from HEMA, NVP, GMMA, EGDMA, MA, TRISS, AIBN, and colorants. Colors available: gray, black, brown, blue, purple, green, brown (chocolate), pink, and combination colors. Packaged in PP cups. Nominal water content: 43%. Recommended replacement cycle: 1 month.

Scope of Application:The product is a daily wear lens, used forCorrection of Myopia in Patients Without Contraindications。

# 07 New Industry Ophthalmology

Product Name:Orthokeratology Rigid Gas Permeable Contact Lens

Product Composition:Product isNight-wear Rigid Gas-permeable Contact Lens for OrthokeratologyThe lens material is a rigid gas-permeable acrylic material, composed of methyl acryloyloxypropyl tris(trimethylsiloxy)silane, hexafluoroisopropyl methacrylate, ethylene glycol dimethacrylate, methacrylic acid, 1,3-bis(methacryloyloxypropyl)-1,1,3,3-tetrakis(trimethylsiloxy)disiloxane, methyl methacrylate, hydroxyethyl methacrylate, colorants, and initiators. The lens colors are purple and gray.The product is not sterile and needs to be disinfected with the recommended care solution according to the instructions before use.。

Scope of Application:The product is suitable for wearers who meet the requirements of the product instructions, with myopia ranging from -1.00D to -4.00D and astigmatism not exceeding 1.50D.Temporary Correction of Myopia。

# 08 Shuochuang Medical

Product Name:Preloaded Intraocular Lens

Product Composition:ProductComposed of an intraocular lens and an injector.. The intraocular lens isSingle-piece posterior chamber intraocular lens, foldable, with an improved C-loop design, monofocal, aspherical optical design. The main body and support parts are made of hydrophobic acrylate material, with added UV absorber and blue light filtering chromophore. The injector consists of a pusher and an insertion head, where the pusher is composed of a plunger, outer shell, spring, sleeve shell, and silicone pad. The front end of the plunger is fitted with a silicone pad. The insertion head is mainly made of polypropylene material, with its inner cavity surface treated with hydrophilic lubrication.

Scope of Application:The product is suitable for intracapsular implantation, used forVision Correction for Aphakic Eyes in Adults After Cataract Surgery。

# 09 Century Kangtai

Product Name:Rigid Gas Permeable Scleral Contact Lens

Product Composition:Product isDaily Wear Rigid Gas Permeable Scleral Contact Lens. The lens material is a fluorosilicone acrylate polymer with high oxygen permeability, and ultraviolet additives.Absorber, lenses belong to UV absorption category 2 lenses. Light blue or transparent color,Product provided in a non-sterile state, the recommended replacement cycle is one year.

Scope of Application:The product is a daily wear rigid gas permeable scleral contact lens, suitable forCorrecting Irregular Astigmatism, can simultaneously correct myopia and hyperopia within the range of -25.00 to 25.00, and regular corneal astigmatism ≤4.00D.Refractive ErrorPatient.

# Global Leading Ophthalmic Device and Consumables Company

# Chinese Ophthalmic Devices and Consumables Companies

# China Ophthalmology Medical Services Company

# Overseas Ophthalmology Startups