Instruction for Use
Prescription Eyewear
Designation: Prescription Spectacle (UMDNS 11-667, GMDN Code 35065)
Product Category: Ophthalmic Devices– Class I Medical Device– Non-invasive, non-active, non-implantable ophthalmic devices intended to compensate for a visual impairment.
Product Description: Spectacle frames are a device worn in front of the eyes with two lens elements used to correct vision problems such as nearsightedness (myopia), farsightedness (hyperopia), and astigmatism.
Intended Use: Pair’s Ophthalmic Eyewear is designed for individuals requiring vision correction due to refractive errors such as myopia (nearsightedness), hyperopia (farsightedness), astigmatism, or presbyopia. This eyewear is intended for daily wear to improve visual acuity for various activities including reading, driving, and general day-to-day tasks.
Special Feature: The eyewear includes Integrated magnets for the optionally secure attachment of decorative and functional top frames.
Materials:
Frames: Lightweight, hypoallergenic composite material, designed for durability and comfort.
Lenses: High-quality optical grade polycarbonate, MR7, MR8, or CR-39 material, customizable with a range of vision correction prescriptions. All Pair lenses include anti-reflective and scratch-resistant coatings.
Product Specifications:
Frame Size: Available in multiple sizes to fit a range of face shapes and sizes.
Lens Options: Single vision, bifocal, and progressive lens options available to accommodate various types of vision correction needs.
Color Options: A variety of frame and clip-on colors and styles to suit personal preferences.
Instructions for Use:
Wear: Ensure comfortable fit. Have adjustments made by an optician.
Clean: Wipe with a soft microfiber cloth. For deeper cleaning, use lens cleaner or water. Avoid abrasives and harsh cleaners.
Maintain: Check regularly for damage. If damaged, see optician.
Store: Keep in a case to protect. Avoid extreme temperatures.
Handle: Use gently and with clean hands. Use both hands for putting on or taking off.
Chemicals: Avoid exposure to chemicals, sprays, and perfumes. Rinse with water if exposed.
Following these instructions will help maintain the quality and longevity of your PAIR
Use Environment for Prescription Spectacles:
These prescription spectacles are designed for everyday indoor and outdoor use in normal environmental conditions. The spectacles are intended for personal use in common daily activities such as reading, driving, and general day-to-day tasks, within a temperature range of 10°C to 35°C (50°F to 95°F) and humidity levels of 20% to 80% non-condensing.
Contraindications
To ensure safety and effectiveness, these prescription spectacles should not be used under the following conditions:
Material Sensitivity: Do not use if you have known allergies or sensitivities to any materials specified in the spectacles, such as certain metals or plastic composites used in the frames.
Protective Requirements: These spectacles are not designed for use as safety goggles and do not provide protection in environments that require impact-resistant eyewear or specific optical filters (e.g., UV protection in industrial settings).
Extreme Conditions: Avoid use in environments with extreme temperatures or high humidity, which may affect the performance and physical integrity of the spectacles.
Use by Children: Prescription spectacles for children should be dispensed by a licensed optical practitioner.
It is essential to consult with a healthcare professional or optician if you are unsure about the applicability of these spectacles to your personal health conditions or activities.
Precautions
To ensure the optimal use and safety of your prescription spectacles, please observe the following precautions:
Driving and Operating Machinery: When first using your spectacles, particularly if they are bifocal or progressive lenses, allow a period of adjustment before engaging in activities such as driving or operating machinery. Initial adaptation can affect depth perception and clarity, which are critical for these activities. Ensure you are comfortable with the visual adjustment to avoid accidents.
Direct Sunlight Exposure: Avoid leaving your spectacles in direct sunlight, such as on a car dashboard. Prolonged exposure to high temperatures can deform the frames and damage the lens coatings, impairing both the comfort and the visual quality of your spectacles.
Screen Use: Prolonged exposure to computer screens and other digital devices can lead to eye strain. To minimize discomfort, follow the 20-20-20 rule: every 20 minutes, take a 20-second break to look at something 20 feet away. This practice helps to reduce the strain on your eyes from continuous screen use.
Emergency Situations: It is advisable to have a backup pair of spectacles, if possible. Having an additional pair can be crucial if your primary spectacles are lost or damaged, ensuring that you do not face any interruptions in necessary vision correction.
MDRCoding:
MDN 1206 Non-active non-implantable ophthalmologic devices
MDT 2001 Devices manufactured using metal processing
MDT 2002 Devices manufactured using plastic processing
EMDNCoding (europa.eu):
Q0210 - Corrective ophthalmic devices
↳ Q02100203 - Metal and plastic spectacle frames without lenses
↳ Q02100101 - Organic ophthalmic lenses (Plastic materials)
Sun Filter Top Frame
Designation: Magnetically attachable sun filter
Product Category: Category I Personal Protective Equipment (PPE)
Product Description: Pair’s Sun Tops are a magnetically attachable accessory designed to enhance the functionality of prescription spectacles by providing protection against solar radiation. The top frame fits securely on Pair’s eyewear, offering additional UV protection and glare reduction.
Intended Use: The product is intended to protect the eyes from the harmful effects of UV radiation while complementing the aesthetic and functional aspects of Pair’s Prescription Spectacles. It is suitable for use in various outdoor environments where sunlight exposure is expected, including walking, hiking, and casual outdoor activities.
Materials:
Frames: Durable, hypoallergenic plastic composite.
Lenses: High-quality polarized material with UV400 protection.
Product Specifications:
Compatibility: Specifically designed to attach to Pair’s Prescription Spectacle frames.
UV Protection: 100% UV400.
Filter Category: 3 (High protection against sun glare, suitable for bright sunlight).
Instructions for Use:
Attach: Align the top frame with the magnets on your Pair’s Prescription Spectacles and gently place it to secure.
Remove: Gently pull the top frame away from the spectacles, taking care not to bend or twist the frames.
Clean: Clean with a soft microfiber cloth. For deeper cleaning, rinse under running water with a mild liquid cleaner and dry with a soft cloth.
Store: Keep in a case when not in use to protect against damage.
Handle: Use both hands when attaching or removing the top frame to avoid stressing the frame and lenses.