CE Certified Prescription Eyewear Factory & Suppliers

Global Ophthalmic Manufacturing Standards & Custom B2B Contact Lens Solutions

Executive Summary

The Global Prescription Eyewear Landscape & Regulatory Benchmarks

The global corrective optical industry is undergoing a structural paradigm shift driven by demographic shifts, escalating rates of myopia, and the convergence of medical efficacy with cosmetic customizability. As corrective contact lenses transition from purely functional devices to lifestyle accessories, managing the regulatory landscape—most notably the CE Certification Framework (MDR EU 2017/745)—becomes paramount for international brands, wholesalers, and healthcare distributors.

For B2B buyers and brand operators, partnering with a fully compliant manufacturer is not merely an operational convenience; it is a fundamental pillar of risk mitigation and market access. Shenzhen Fresh Vision Co., Ltd. serves as an industry-leading OEM/ODM partner, integrating high-level material science with state-of-the-art optical manufacturing infrastructure to deliver certified prescription contacts that comply with global public health directives.

Optics Factory Sterile Lab Area ISO 13485 Facility
10+ Years Industry Experience
1,100㎡ Sterile Production Area
100% OQC In-Line Inspection
5 Eng. R&D Specialist Team

Macro Industry Solutions & Global Compliance

Navigating regional optical standards requires technical compliance, sterile manufacturing protocols, and end-to-end traceabilities.

Global Market Penetration

Exporting to highly regulated domains like North America (25%), Southeast Asia (20%), and the Middle East (10%) requires a robust understanding of medical regulatory landscapes, enabling smooth market penetrations and brand reliability.

MDR EU 2017/745 Compliance

Corrective contact lenses are classified as Class IIa or Class IIb medical devices. Our facilities adhere to strict European Medical Device Regulation requirements, including comprehensive risk assessments and bio-compatibility profiles.

Traceability Protocols

We guarantee full tracking of raw chemical components (monomers, polymer initiators, and dynamic color pigments). Each production batch undergoes comprehensive logging to ensure consumer safety and strict regulatory transparency.

High Tech Optical Production Clean Room Est. 2016-01-26
Corporate Overview

Shenzhen Fresh Vision Co., Ltd.

Established on January 26, 2016, Shenzhen Fresh Vision Co., Ltd. has grown to become a premium manufacturer of contact lenses, medical-grade ophthalmic solutions, and customizable cosmetic eyewear. operating an advanced 1,100 square meter production facility equipped with high-precision molding and automated sterilization lines.

With over 10 years of export experience, we cater to brand businesses, retailers, wholesalers, and manufacturers across the globe. Our operational workflows are optimized for multilingual commercial collaboration, with active commercial support in Spanish, English, and Chinese.

  • Robust Quality Control: Product inspection method covers inspection of all products, random inspection, and custom validation according to client's specific requirements.
  • Dedicated R&D Unit: Five specialized engineers (3 holding graduate degrees, 2 junior college) running advanced materials assessment programs.
  • Flexible Customization: Full support for sample processing, graphic styling, and customized on-demand packaging layouts.

The Ophthalmic Production & Quality Control Pipeline

Every step in our ISO 13485 cleanroom environment is automated and verified to guarantee optical centering, hydration stability, and surface smoothness.

Demoulding step
Step 01

Precision Demoulding

Carefully releasing cured hydrogel matrices from precision-turned molds without creating micro-tears or edge imperfections.

Soak and disinfect step
Step 02

Soak & Disinfect

Purging remaining monomer residues through continuous hydration baths to secure high bio-compatibility and ocular safety.

Film Suction step
Step 03

Vacuum Film Suction

Automated pick-and-place transfer systems using medical-grade vacuum cups to safely transport wet lenses between processing trays.

Inspecting step
Step 04

Visual Inspection

High-resolution projection systems verify structural circularity, edge contours, and check for presence of micro-air bubbles.

Filling step
Step 05

Saline Filling

Injecting exact quantities of buffered, isotonic saline solution containing wetting agents to maintain long-term lens equilibrium.

Sterilization step
Step 06

Autoclave Sterilization

High-temperature steam sterilization cycles inside pressurized cabinets to eliminate bacterial endospores.

Packing step
Step 07

Blister Packaging

Sealing lenses inside medical-grade composite PP cups with medical-grade aluminum lidding foil to ensure sterile barrier integrity.

OQC step
Step 08

Outgoing Quality Control (OQC)

Statistical quality audits verification to check package seal force, correct label printing, and lot number coding.

Customizations

Tailor-Made Solutions

Need specialized packaging, custom base curves, or graphic styling? Our engineers design tailor-made manufacturing runs for your specific business requirements.

View Technical FAQ →

Equipment Directory & Optical Instruments

Our facility relies on high-grade clinical instrumentation to maintain product integrity and check correct material formulation.

Demoulding Machine
Demoulding Machine
Film Suction Machine
Film Suction Machine
Filling Machine
Filling Machine
Sterilization Cabinet
Sterilization Cabinet
Packaging Machine
Packaging Machine
Focimeter
Focimeter (Diopter Check)
Projector
Optical Projector
Spectral equipment
Spectral Equipment

Looking for custom technical parameters?

We support custom base curves (BC), diameters (DIA), and high-diopter corrections.

Technical Specification & Ocular Safety Parameters

When engineering prescription color contacts, maintaining a proper balance between material softness, oxygen permeability (Dk value), and water content is essential. Soft contact lenses are manufactured using hydrophillic copolymers (like HEMA) or advanced silicone hydrogels that absorb water to stay pliable, soft, and comfortable.

Our research and development processes focus on optimizing the lens profile. An ultra-thin edge design reduces interaction with the eyelid during blinking, minimizing foreign body sensation. By incorporating advanced UV filters into the monomer mixture, we help protect the cornea and internal ocular structures from harmful ultraviolet radiation.

Color Integration Technology: Traditional cosmetic lenses can carry risks of pigment migration if the colorants are printed directly onto the lens surface. Fresh Vision utilizes a Sandwich Injection Molding technology. The color layer is fully encapsulated between two thin layers of clear hydrogel material. This prevents pigments from making contact with the cornea or palpebral conjunctiva, maintaining safety during daily wear.

Clinical Inspection Microscope Spectral Testing Approved

B2B Supply Chains, Custom Packaging & OEM/ODM Solutions

1. Custom Packaging OEM/ODM

We offer end-to-end customization of packaging solutions, including blister foils, custom paper boxes, outer cartons, and complete multi-lens kits. We support brand owners in developing unique, localized retail presentations that comply with local labeling regulations.

2. Low Minimum Order Quantities (MOQs)

We understand that dynamic market testing requires flexibility. We offer scalable order sizes for private labels, helping distributors introduce new colors, seasonal designs, or unique correction ranges without excessive initial inventory risk.

3. Direct Logistic Channels

Leveraging our strategic location in Shenzhen, we utilize reliable air and sea shipping networks. This helps maintain stable shipping lead times to key hubs in North America, Europe, Southeast Asia, and the Middle East.

Interested in starting a custom brand run? Contact our multilingual account managers to get started on your technical dossier and sample runs.

Technical & Commercial FAQ

Key compliance and production details for purchasing managers, optometrists, and private label importers.

Q1: What specific CE and ISO certifications do your contact lenses carry?
Our manufacturing processes follow EN ISO 13485 quality management system requirements for medical devices. Our lenses are CE certified under the European Medical Device Regulation (MDR), ensuring compliance with health, safety, and environmental standards. We provide complete technical files (including bio-compatibility assessments, sterilization verification, and stability data) for international product registration.
Q2: Can we customize parameters like base curves, diameter, and water content?
Yes, our R&D team can adjust base curves (BC) from 8.4mm to 8.7mm and overall diameters (DIA) from 14.0mm to 22.0mm. We offer hydrogel materials with water contents ranging between 38% and 42% to balance durability, mold stability, and oxygen permeability.
Q3: How does your sandwich color technology protect the eye?
Our sandwich encapsulation method prints the design onto the inner surface of the bottom mold, curing it, and then sealing it with a second layer of monomer formulation. This traps the dye within the hydrogel matrix, preventing direct contact between pigments and the corneal surface, which reduces risks of pigment leaching or corneal abrasion.
Q4: What is the typical shelf life and sterilization methodology for these lenses?
Our daily, monthly, and yearly replacement lenses undergo wet heat sterilization in autoclave cabinets (reaching 121°C for at least 20 minutes). Packaged in sealed PP blisters with high-grade aluminum foil, the lenses maintain a verified sterile shelf life of up to 5 years from the date of manufacture.
Q5: Do you support custom branding and what is the typical OEM turnaround time?
We provide full OEM and ODM services, including customized blister foils, cardboard boxes, and color cards. After finalizing packaging artwork, the standard production timeline is typically 25 to 35 days, depending on batch size and color configuration.
Q6: How do you handle Raw Material Traceability and Quality Control audits?
All raw material components are sourced from validated, medical-grade chemical suppliers and logged under internal tracking codes. Quality checks are performed at multiple stages: raw monomer check, demoulding inspection, projector profiling, and 100% OQC (Outgoing Quality Control). We welcome third-party audits and offer custom testing plans to align with client-specific standards.