3N Eyecare Launches World’s First Rigid Contact Lens Care Device, Secures NMPA Class III Innovative Medical Device Approval

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3N Tech Hard Scope Restorer Full Dimension (Left) and Portable Version (Right)

# Research and Development Background

Corneal hypoxia, corneal epithelial staining, corneal pigment ring, corneal deformation, glare, decreased visual quality, and even corneal pathogenic microbial infections... are allCorneal Complications Possibly Caused by Wearing Contact Lenses。

With the increase in the number of people with myopia, the popularity of orthokeratology lenses (OK lenses), and the market launch of rigid scleral contact lenses, a series of issues arising from wearing rigid contact lens products have gradually begun to attract widespread attention.

Apart from the mechanical friction between the lens and the cornea caused by wearing issues,Protein precipitation is also a major cause of corneal complications.When lens care is poor and they are not cleaned properly, protein deposits accumulate, which not only reduces visual acuity and the oxygen permeability of the lenses, affecting oxygen transmission, but also interferes with the disinfection effectiveness of the lenses.

The registration information of medical enterprises by the National Medical Products Administration shows,The minimum protein removal rate of most contact lens care solutions on the market is 6%.In other words, up to 94% of protein can still remain deposited on the lenses after cleaning with the care solution, which is highly conducive to bacterial growth. When the number of bacterial colonies on the lenses exceeds a certain level, the care solution cannot guarantee its sterilization effect, thereby increasing the risk of eye infections.

Compared with traditional rigid contact lens care solutions, 3N Tech's Rigid Contact Lens Protein Remover and Sterilization Care Device has "Simple composition, convenient operation, dual effects combined, high safety and acceptability"The characteristics."

• In terms of composition, only needs to be used with 0.9% sterile sodium chloride solution, and contains no preservatives.

• In operation`, only need`Place the lenses into the device and press the button, follow the instrument's prompts for operation. No manual soaking or rubbing is required. Standard care is completed in 15 minutes, and intensive care in 30 minutes, improving patient compliance.

• In terms of effectiveness, granting 0.9% sterile sodium chloride solution the ability to clean and disinfect rigid contact lenses—something it does not inherently possess—with an effectiveness comparable to existing rigid contact lens care solutions.

• In terms of safety, has successively carried out pre-market clinical trials in multiple authoritative ophthalmic hospitals in China, and achieved ideal clinical data. The subjects showed a high acceptance of the device and gave positive feedback on its comfort.

Protein Removal Effect

Certified by both U.S. FDA 510K and CNAS National Laboratory, 3N Tech Contact Lens RestorerProtein removal rate reaches over 95%No obvious bands were seen on the electrophoresis gel below. After instrument cleaning, the protein on the lens infrared spectrum disappeared, and no significant residual fluorescence-labeled protein was observed.

Sterilization Effect

According to a test report provided by 3N Tech, it can be seen that,The bacterial kill rate of this technology is ≥99.999%, and the fungal kill rate is ≥99.99%.`, much higher than the standards of care solutions currently available on the market.`

# Clinical Trial Results

Led by multiple leading experts in the field of contact lenses, in collaboration with Beijing Tongren Hospital, Wenzhou Medical University Eye Hospital, Central Theater Command General Hospital, Guangzhou Aier Eye Hospital, and Shenyang Aier Eye Hospital.Multicenter real-world clinical study verification conducted in collaboration with five Class III Grade A ophthalmology hospitals：3N Rigid Contact Lens De-Protein and Sterilization Care Device (RigidCare）HasBetter protein removal and sterilization effects。

OK lens wearers from five hospitals used trial lenses and personal lenses for disinfection and sterilization evaluation as well as protein removal assessment. The control group used Menicon multipurpose solution and protein remover (Menicon Co., Ltd.).

▲Group Analysis Results of Clearance at Different Levels of Protein Deposition(FromCont Lens Anterior Eye）

# 3N Tech

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