Product Information
About the Product
A pack of ten white DMV Vented Scleral Cups. Each one is a small hand held cup on a shaft that carries a contact lens to the eye. The shaft is vented all the way through, so an air channel runs its full length and no suction can build. The moulded body contains dry natural rubber and does not contain liquid latex. Made in the United States.
This is the insertion cup in the DMV range, used for scleral lenses, hybrid lenses, soft contact lenses and prosthetic eyes. Because the vent disables suction, the lens rests on the cup and transfers onto the eye instead of adhering to the tool, which is what separates it from the solid DMV Scleral Cup. It is an inserter only and is not used to take a lens off the eye. The pack of ten suits the six month replacement schedule and keeping spares in more than one place.
Materials
- Dry natural rubber The moulded body of the tool. It does not contain liquid latex, a known allergen.
Specifications
| Pack size | 10 cups |
|---|---|
| Colour | White |
| Function | Insertion only |
| Venting | Vented through the full length of the shaft, which disables suction |
| Lens types | Scleral, hybrid and soft contact lenses, and prosthetic eyes |
| Country of manufacture | United States |
How to Use
- Hold the device in a vertical position and place the contact lens in the cup.
- Fill the lens with approved solution when inserting hybrid or scleral lenses.
- Carefully raise the device to the open eye and touch the lens to the eye by using a mirror.
Care and Cleaning
- Clean the device with 70% isopropyl alcohol after every use and allow it to air dry.
- Store the device in its case once it is dry.
- Plan to replace it every six months.
Warnings
- Do not use this device for removal of contact lenses.
- Do not apply the device to the eye surface with sliding motions.
- Keep away from hand cream, hair gels, nail polish remover and oxidizing agents.
- Choking hazard. Keep this and all other medical devices away from small children.
- Not recommended for use on diseased or injured eyes.
- Consult an eye care professional in case of irritation, visual impairment or pain.
Storage
- Do not store warmer than 105 C / 220 F.
- Protect from direct sun.
Regulatory
Class I medical device, exempt from premarket notification. Listed with the FDA under product code KYE, regulation 21 CFR 886.5420, contact lens inserter/remover, ophthalmic panel.
| Proprietary name on the FDA listing | DMV Vented Scleral Cup |
|---|---|
| Product code | KYE |
| Regulation number | 21 CFR 886.5420 |
| Regulation description | Contact lens inserter/remover |
| Device class | Class I, 510(k) exempt |
| Establishment | The DMV Corporation, Zanesville, Ohio |
| FDA establishment registration number | 1523955 |
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NDC 24208-730-06
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