Product Information
About the Product
A DMV Scleral Stand supplied with one DMV Vented Scleral Cup. The cup seats in the stand so the cup sits upright and steady while the wearer lowers the eye onto the lens, which makes this a hands free way to insert a scleral lens. The cup is vented through the full length of its shaft, so no suction builds, and its moulded body contains dry natural rubber and does not contain liquid latex. Made in the United States.
This is the hands free option in the DMV scleral insertion range, for people who would rather not balance a cup on a fingertip. Looking down through the stand against a white background gives a target to line the eye up on, and a flashlight held under the light absorbing base gives a lit target instead. It is an insertion set only, so a separate tool is needed to take the lens off the eye.
Materials
- Dry natural rubber The moulded body of the tool. It does not contain liquid latex, a known allergen.
What Is Included
- One DMV Scleral Stand.
- One DMV Vented Scleral Cup.
Specifications
| Contents | 1 stand plus 1 DMV Vented Scleral Cup |
|---|---|
| Function | Hands free insertion |
| Lens type | Scleral lenses |
| Venting | The supplied cup is vented through the full length of the shaft, which disables suction |
| Country of manufacture | United States |
How to Use
- Place the DMV Vented Scleral Cup in the stand.
- Fill the lens with approved solution and place it in the cup.
- Use a white background beneath the stand to create a target, or hold a flashlight against the light absorbing base to create a lit target.
- Look down through the stand and lower the open eye onto the lens.
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 the vented cup for removal of contact lenses.
- Do not apply the cup 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
NDC 24208-585-64
NDC 24208-295-25
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