IOL Cast Moulding Technology and Regulatory Guidelines

Intraocular lenses (IOLs) are tiny artificial lenses implanted inside the eye during cataract surgery. They are used to replace the natural lens that become cloudy as we age. In this blog, we will discuss why IOL cast moulding technology is becoming the gold standard in manufacturing intraocular lenses. Additionally, we have presented the regulatory guidelines for manufacturing IOLs in different regulatory markets.

What is IOL cast moulding technology?

IOL cast moulding technology is a mass-manufacturing process for intraocular lenses (IOLs). The technology involves injecting medical-grade liquid polymer into precision-designed moulds. Then, the polymer is cured with UV light or heat to create a solid lens. This technique ensures consistent lens geometry, better surface finish, and minimal waste of material. This large-scale production technology can be used for complex lens designs, such as toric and multifocal lenses.

IOL cast moulding technology is becoming the gold standard process for manufacturing modern, high-performance IOLs used in cataract and refractive surgeries. This method offers high efficiency and reproducibility compared to traditional techniques, such as lathe-cutting. The cast moulding technology:

• Allows for the efficient, large-scale manufacturing of high-quality IOLs.
• Ensures high dimensional accuracy and optical power for each lens.
• Can be used for the creation of advanced IOL designs, including aspheric, multifocal, and toric lenses.

Why are manufacturers opting for IOL cast moulding technology?

IOL cast molding technology is the new standard in intraocular lens manufacturing. It blends in accuracy, cost-efficiency, and regulatory compliance. By offering precision, repeatability, and efficiency, this technology is reshaping the way IOLs are produced. 

As opposed to traditional lathe-cutting methods, cast molding technology can be used for mass production of high-quality IOLs with complex optical designs. This technology can be used for manufacturing modern IOLs made using hydrophobic and hydrophilic acrylic materials. Moreover, this is an efficient and reproducible process. 

The IOL cast moulding technology process

• Mold design and fabrication: A precision mold, typically made of high-grade stainless steel, glass, or plastic, is used. The mould is created with exact curvatures that define the optical power and geometry of the IOL.
• Polymer preparation: A medical-grade polymer, often hydrophobic or hydrophilic acrylic, is prepared in a liquid state. UV-initiators and other additives are mixed in to ensure the lens will have the proper clarity, strength, and biocompatibility.
• Polymer injection: The liquid polymer is injected into the mold cavity under controlled pressure. This step ensures uniform filling and prevents the formation of air bubbles or other defects.
• Curing: The mold is exposed to ultraviolet (UV) light or heat. This causes the polymer to cure and harden into a solid, stable lens.
• Demolding and finishing: After curing, the hardened lens is carefully removed from the mold. Then, the edges are polished to ensure a smooth, safe, and comfortable fit during surgical implantation.
• Quality control and sterilization: Each lens undergoes rigorous inspection for visual, optical, and dimensional quality. After which, approved lenses are sterilized prior to packaging. 

7 Key advantages

1. High reproducibility: The process consistently produces large batches of identical, high-quality lenses with minimal variation. Notably, this is critical for ensuring patient safety and satisfaction.
2. Mass production and cost efficiency: Cast molding is far more efficient for mass production than older techniques, such as lathe-cutting. Thus, it results in lower manufacturing costs than traditional techniques.
3. Regulatory compliance at every step: Cast molding is a controlled, documented, and validated process. Hence, it meets most regulatory requirements for manufacturing IOL.
4. Design flexibility: The technology can produce complex and advanced IOL designs. It can be used to manufacture multifocal and toric (astigmatism-correcting) lenses.  These lenses were impossible to manufacture using traditional methods.
5. Superior surface finish: Lenses produced by cast molding have a very smooth surface. This minimizes light scattering and improves post-operative visual quality.
6. Less waste: The process is more material-efficient than machine-based methods. This is because it only uses the amount of polymer required for the lens. 
7. Faster time to market: With efficient material use and automation potential, manufacturers can reduce production costs and scale faster. Thus, IOL cast moulding technology process can lead to faster time to market.

Increase in popularity and demand for IOL cast moulding processes

Globally, an increasing number of cataract surgery and advanced visual correction is being performed. This is driving the demand for IOL worldwide. Thus, manufacturers are opting for IOL cast moulding technology for efficient mass production and to meet strict quality and regulatory standards. The demand for the technology is being driven by its high efficiency and ability to produce complex, high-performance lenses for the growing intraocular lens market. This technology is increasingly becoming the industry standard, replacing the less efficient previously used lathe-cutting methods. The demand for intraocular lenses is increasing owing to:

• Aging global population: The number of elderly people is on the rise worldwide. Hence, the incidence of age-related eye conditions, such as cataract, is increasing, thereby increasing the volume of cataract surgeries performed. This is driving the demand for IOLs.
• Growing demand for premium lenses: There is a rapid increase in patient and surgeon preference for premium IOLs, such as multifocal, toric, and extended depth of focus (EDOF) lenses. These advanced designs improve post-operative vision and reduce reliance on glasses. Notably, the cast molding technology is uniquely developed to manufacture these premium IOLs.
• Rising healthcare access in emerging economies: Countries in Asia-Pacific and Latin America are expanding access to eye care, thereby leading to higher surgical volumes. Increased disposable income in these regions also allows more people to afford advanced IOL options, thereby driving their demand.
• Government initiatives: Public health programs and government initiatives have been formulated to eliminate cataract-related blindness. This is driving demand for IOLs in many developing nations, thereby increasing the need for high-volume, cost-effective production methods. IOL cast moulding technology can cater to this demand.
• Medical tourism: The trend of patients traveling to countries for high-quality ophthalmic surgery is also fueling market growth and innovation.

This increase in demand for IOL is translating to increase in adoption of the IOL cast moulding process. Owing to its ability to offer high-quality, scalability, precision and cost-effective solutions, this technology is better positioned to meet this demand.

Global regulatory requirements for manufacturing IOLs

• India: IOLs are classified as Class C. Hence, strict regulatory guidelines will have to be followed for this high-risk medical device. An application has to be filed under Form MD 7 and the license will be granted under MD 9. Additionally, compliance with ISO 13485:2016 QMS will be required.
• EU: IOLs entering the European market will have to follow the EU MDR guidelines. IOLs are classified as Class III devices. Hence, guidelines will have to be followed accordingly. Clinical evaluation, PMS, and UDI compliance will be necessary. Additionally, CE marking by a Notified Body will be required.
• USA: In USA, IOLs will have to follow the US FDA guidelines. Whether a US FDA 510(k) or PMA pathway will be required has to be determined. Clinical trials and extensive product testing will be required.

We have highlighted the regulatory guidelines for IOLs in top regulatory markets. Different countries have different sets of guidelines. Hence, navigating them requires technical know-how, documentation expertise, and regulatory knowledge. Support of a regulatory consultant can make this journey easier.

We at Pharmadocx Consultants have extensive knowledge of regulations for IOL cast moulding technology. We offer license application support, document preparation support, and regulatory guidance. To avail our all-encompassing service, drop an email at [email protected] or call/Whatsapp on 9996859227.