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
CodeName
HQDLens, Contact (Other Material) - Daily

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQDLens, Contact (Other Material) - DailyOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B222010PackageHIBCC1Not in Commercial Distribution
B22201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid-gas-permeable corrective contact lens, daily-wear, non-customizedA 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

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