Bruder Moist Heat Eye Compress and Hygienic Eyelid Sheets, 1 Compress and 35 Sheets

About the Product

A bundle of two items: one reusable fabric eye compress that is heated in a microwave and applied over the closed eyes, and one box of 35 disposable untreated eyelid sheets that are placed between the eyelids and the compress and then used to wipe the lids and lashes. The compress is filled with MediBeads. The beads have a honeycomb shaped pore and absorb only water molecules from the air while rejecting body oils and other organic fluids, so no water is added before use. Silver is present in the bead. The compress is latex free, and completely hand washable and reusable, so no cover is required. The eyelid sheets are untreated, unfragranced micro fine sheets, individually wrapped. They are not pre-moistened and carry no added ingredients.

The bundle pairs the warm compress with the disposable sheets that are used under it. A sheet is placed between the closed eyelids and the warmed compress for the 8 to 10 minute application and is then used to wipe oil, debris and makeup from the lids and lashes, which also keeps the compress cleaner between washes.

Materials

• MediBeads fill Specially formed and treated beads with a honeycomb shaped pore that absorb only water molecules from the air and release that moisture as moist heat when the compress is warmed, so no water is added before use.
• Fabric shell The hand washable fabric that encloses the beads and holds the contoured shape worn over the closed eyes, so no separate cover is required.
• Adjustable strap The strap that holds the compress in position over the eyes, which can be left off if preferred.
• Untreated micro fine sheets Dry sheets carrying no solution, fragrance or added ingredients, each individually wrapped and used once.

What Is Included

• One Bruder Moist Heat Eye Compress with adjustable strap
• One box of Bruder Hygienic Eyelid Sheets, 35 individually wrapped sheets

Specifications

How to Use

1. Before heating, place compress on a microwave safe plate to keep it clean.
2. Set plate on the rotating tray and microwave for 20 seconds. To increase heat, warm in additional 5 second increments. Do not exceed 30 seconds total.
3. Touch test compress before placing over eyes. If the compress feels too hot, remove immediately and wait 1 to 2 minutes before reapplying.
4. Open a sealed Bruder Hygienic Eyelid Sheet, unfold it and place it between the warmed compress and your eyes. The sheets are optional.
5. Apply for 8 to 10 minutes over closed eyes or as prescribed by your doctor.
6. After treatment, gently wipe oil, debris and makeup from the eyes and lashes with the sheet, then dispose of it. The sheets are designed for single use.
7. If the compress is reused within 30 minutes, reduce heating time by half.

Care and Cleaning

• Wait 2 hours after use before washing.
• Hand wash only in cold water with a mild detergent.
• Air dry for at least 24 hours before use.
• Wash if exposed to makeup, creams, oils, grease or food.
• The compress does not need to be washed after every use. Wash it if it becomes soiled.
• Hand washing and air drying are recommended over machine washing and machine drying.
• If using daily, consider replacing after 6 months.
• The eyelid sheets are disposable and are not washed or reused. Using a sheet reduces the frequency with which the compress needs to be washed.

Warnings

• Remove racks and shelves from microwave prior to heating.
• Do not exceed 30 seconds total heating time.
• Touch test compress before placing over eyes. If the compress feels too hot, remove immediately and wait 1 to 2 minutes before reapplying.
• Microwave ovens vary greatly. Use a medium setting and always touch test the product before placing it directly on the eyes or skin.
• Compress should not be applied tightly and can be used without the strap if desired.
• At least 30 minutes is recommended before reheating. If reheating, reduce the heat time by half.
• After treatment, you may experience blurry vision that will clear in a few minutes as your tear glands are releasing beneficial fluids.
• After eye surgery, every case is different, so consult your surgeon or support staff for instruction.

Regulatory

This product is listed with the FDA by The Hilsinger Company Parent, LLC, 575 West Street, Suite 120, Mansfield, MA 02048, under FDA establishment registration number 1039131. In that registration the proprietary names Bruder and MediBeads appear under product code IMA, device name "Pack, Heat, Moist", regulation number 21 CFR 890.5730, device class 1, and also under product code IME, device name "Pack, Hot Or Cold, Reusable", regulation number 21 CFR 890.5700, device class 1.

Both 21 CFR 890.5730 and 21 CFR 890.5700 classify their devices as Class I (general controls) and state that the device is exempt from the premarket notification procedures in subpart E of part 807. There is therefore no 510(k) number for this product, and none is required. Nothing here should be read as a statement of FDA approval or clearance.

No product code in the retrieved openFDA registration listing for establishment 1039131 names eyelid sheets, hygienic sheets or lid sheets, so no regulatory status is claimed here for the sheets component.