Identity
- Trade Name
- Optacryl 60 FDA UDI
- Generic Name
- Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
- Device Name
- Optacryl® 60 (kolfocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut firm contact lenses with spherical anterior and posterior surfaces. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The Optacryl® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The lens material is available in blue, green, or gray versions. The blue lens contains Microlith Blue 4 G-K; the green lens contains Sunfast Green No. 7; and, the gray lens contains D&C Green No. 6, D&C Violet No. 2, and Perox Yellow No. 9 as the color additives. FDA UDI
- Model / Reference
- Optacryl 60 FDA UDI
- Description
- Optacryl® 60 (kolfocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut firm contact lenses with spherical anterior and posterior surfaces. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The Optacryl® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The lens material is available in blue, green, or gray versions. The blue lens contains Microlith Blue 4 G-K; the green lens contains Sunfast Green No. 7; and, the gray lens contains D&C Green No. 6, D&C Violet No. 2, and Perox Yellow No. 9 as the color additives. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B22201 FDA UDI
- FDA Product Code
- HQD FDA UDI
- GMDN Term
- Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5916 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid-gas-permeable corrective contact lens, daily-wear
Optacryl 60 by Paragon Vision Sciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Paragon Vision Sciences
Sources (1)
- FDA UDI 99ecc4f4-eba0-48bc-8648-303551e10cf0 33 fields · synced May 30, 2026