Home GUDID B22201 Optacryl 60
Primary DI B22201
Brand Optacryl 60
Company Paragon Vision Sciences, Inc.
Model Optacryl 60
Device description Optacryl® 60 (kolfocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut firm contact lenses withspherical anterior and posterior surfaces. The posterior curve is selected so as to properly fit an individual eye and the anterior curve isselected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allowstear 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 containsSunfast 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.
Published 2017-10-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HQD Lens, Contact (Other Material) - Daily
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HQD Lens, Contact (Other Material) - Daily Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B222010 Package HIBCC 1 Not in Commercial Distribution B22201 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Rigid-gas-permeable corrective contact lens, daily-wear, non-customized A prefabricated (non-customized) rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device.
Regulatory Flags# DUNS number 028594987 Device count 1 Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B22202 Paraperm O2 Paraperm O2 2018-02-23 B22221 Paragon Z CRT Paragon Z CRT 2021-04-05 B22222 Paragon Z CRT Dual Axis Paragon Z CRT Dual Axis 2021-04-05 B22203 Paraperm EW Paraperm EW 2018-02-23 B22211 FSA 38 FSA 38 2018-03-16 B22214 FSA 52 FSA 52 2018-03-16 B22215 SportSight GP SportSight GP 2018-02-23 B22216 HDS HI 1.54 HDS HI 1.54 2018-02-02 B222700 Single Lens BillBoard 700 2017-12-08 B222750 Bi-Lens BillBoard 750 2017-12-08 B22225 Oxfore100 Oxfore100 2023-09-18 B22204 Fluoroperm 92 Fluoroperm 92 2018-03-23 B22205 Fluoroperm 60 Fluoroperm 60 2018-03-23 B22206 Fluoroperm 30 Fluoroperm 30 2018-03-23 B22207 Fluoroperm 151 Fluoroperm 151 2018-03-23 B22208 Paragon HDS Paragon HDS 2018-03-23 B22209 Paragon HDS100 Paragon HDS100 2018-03-23 B22212 Paragon Thin Paragon Thin 2018-03-23 B22217 Paragon CRT Paragon CRT 2021-04-05 B22218 Paragon CRT100 Paragon CRT 100 2021-04-05
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