Contact lens packaging plays an important role in ensuring product safety, sterility, and regulatory compliance. Whether you're manufacturing disposable lenses or reusable options, the right packaging must meet strict FDA guidelines.
The Food and Drug Administration establishes and enforces regulation for contact lens packaging. They carefully monitor products, packaging, and labeling to ensure compliance with applicable regulations. These regulations cover the types of materials that manufacturers can use, package seals, and sterilization requirements.
What Regulations Apply to Contact Lens Packaging?
Several regulations cover contact lens packaging design and composition. All manufacturers must register with the FDA and list all contact lens products with the agency. Ophthalmic solutions are also closely regulated.
Under FDA rules, most prescription contact lenses are considered Class II medical devices that pose a moderate risk. All products and packaging fall under the regulations established by the Federal Food, Drug, and Cosmetic Act. The main federal regulation covering contact lens packaging is 21 CFR § 800.12, covering tamper resistance, contact lens solutions, and labels.
Like other packaging, optical lenses should always follow industry best practices. In this case, that means complying with standards established by the FDA, International Organization for Standardization, and Federal Trade Commission.
Contacts sold outside of the U.S must also comply with applicable regulations in the destination country. For example, they fall under the Medical Device Regulation (EU) 2017/745 in the European Union.
Contact Lens Packaging Solution Rules
The solutions used to support contact lenses during storage are strictly regulated. Strict pre-approval processes are required to ensure compliance with 21 CFR § 800.12. Products must undergo sterility testing and be kept in tamper-resistant packaging. That packaging must contain identifying information.
Saline used for contact lens storage and packaging has a discard date. Manufacturers should put this on all package labels.
Packaging Material and Design Regulations
Contact lens packaging design should protect its contents from physical damage. In the case of glass vials, this often means using protective wraps or segmented trays. Thermoforming is an excellent process for making trays that accommodate individual vials. It can also be used to create blister packs for disposable contacts.
Only medical-grade materials should have direct contact with lenses, and glass vials meet this requirement. So do several types of medical-grade plastics.
There are many packaging considerations beyond maintaining regulatory compliance. For example, many manufacturers prefer cost-effective solutions for product storage and shipping. There are also concerns about sustainability. Plastic packaging materials address these concerns without compromising durability.
Labeling Requirements
All medical products and drugs sold in the United States face strict labeling requirements. FDA standards require clear Unique Device Identifiers on each disposable contact lens package to help with traceability. Products without UDIs face possible impoundment, and manufacturers may incur fees for this infraction.
In addition to a UDI, all contact lens labels must include the following information:
- Expiration date
- Identifying and traceable lot number
- Manufacturer name and location
- Prescription information
- Sterility symbol
- Storage conditions
In addition, labeling must contain instructions for use and any warnings or precautions. Labeling can be on the outside of the packaging or in a package insert. Another requirement established by the FDA covers label accuracy. False, incomplete, or misleading claims are not allowed on any contact lens packaging.
EU Regulations for Contact Lenses
Any manufacturer shipping contacts to the EU must comply with the Medical Device Regulation (EU) 2017/745. This prioritizes safety and risk management. It has strict rules for package labeling that are largely in line with the FDA’s. For example, labels must display a UDI, expiration date, safety information, and sterility markings. All contact lenses must also be registered with the European Union Database on Medical Devices.
How Are Contact Lenses Packaged?
Contact lenses require special packaging that preserves their flexibility while limiting the risk of contamination. The most common types of packaging used for contacts are glass vials and foil and paper blister packs.
Once contact lenses emerge from manufacturing, they undergo a comprehensive quality control inspection. From there, they are packaged in either vials for multi-use lenses or blister packs for single-use lenses.
The packages are filled with saline to preserve the lenses and ensure they remain usable. Once filled, special tamper-resistant seals are added to the contact lens packaging to conform with FDA regulations. The finished products then undergo a sterilization process, after which they can be stored or shipped to customers.
Are There Special Considerations for Contacts and Other Optical Devices?
In additio to meeting health and safety concerns, contact lenses and other optics require special handling to retain their properties. For example, optics usually need specific storage conditions that minimize exposure to light, static, and excess humidity. Contact lens storage and packaging systems should maintain these conditions to reduce the risk of lens degradation.
What Is the Liquid in Contact Lens Packages?
Most contact lenses are packaged in a buffered saline solution. This is a very weak saltwater solution. It often includes small amounts of buffers to help maintain appropriate pH levels. Some manufacturers add polymers to boost hydration and make the lenses more comfortable for wearers.
- Hydration: Storage in a liquid like saline solution allows contact lenses to remain hydrated, keeping them soft and flexible.
- Preservation: Contact lens solutions protect the lenses from contamination during storage and transportation.
- Sterility: Both contact lenses and the solutions used in their packaging are sterile. Once sealed in tamper-resistant packaging, the saline solution helps to ensure that the lenses arrive to users completely sterile.
Saline contact lens packaging solution is not the same as contact lens solution. Standard contact lens solution typically contains preservatives, wetting agents, and disinfectants and is used by contact wearers to disinfect lenses between uses and enhance comfort. Proper labeling helps to limit confusion between the two products.
Solutions for Contact Lens Packaging
Ready-Made Plastic Trays has over 30 years of experience creating stock and custom thermoformed plastic trays for medical devices and optical equipment. Our trays are ideal for storing contact lenses throughout the manufacturing process and transporting them safely. We can supply trays made from sustainable medical-grade plastic to meet most contact lens packaging needs. Contact us to request a sample.
