Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consisting of four zones: The central spherical or aspheric zone, an…
Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consisting of four zones: The central spherical or aspheric zone, an annular “Reverse Zone(s)”surrounding the central zone with a curvature steeper (shorter radius) than the central zone, an “Alignment Zone(s)” generally paralleling the underlying corneal surface and peripheral curve(s) with a radius selected to create “edge lift” to promote tear flow under the lens and avoid impingement of the peripheral curve on the cornea. The lens design also includes a “rounded” edge terminus extending from the anterior to the posterior surfaces to promote comfort. Paragon RG-4 Contact Lenses for Corneal Reshaping are to be worn overnight with removal during all or part of each following day. The material is a thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for corneal reshaping are available as lathe cut firm contact lenses with blue, green, red and yellow tints containing D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.
Who Else Makes It
Registered in Tianjin.
Record
Regulatory record for Paragon RG-4 | Listed by | Paragon Vision Sciences, Inc., United States |
| FDA product code | NUU |
| Device type | Lens, Contact, Orthokeratology, Overnight |
| Device class | Class 3 |
| Regulation | 21 CFR 886.5916 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2021-04-05 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.