FDA.reportPublic FDA data

Optacryl 60

Primary DI
B222010
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 with spherical anterior and
Published
2017-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
B222010PackageHIBCC1In Commercial Distribution
B22201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid-gas-permeable corrective contact lens, daily-wearA 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. The lens may last for years and is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
185530029
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B22202Paraperm O2Paraperm O22018-02-23
B22221Paragon Z CRT Paragon Z CRT 2021-04-05
B22222Paragon Z CRT Dual Axis Paragon Z CRT Dual Axis2021-04-05
B22203Paraperm EWParaperm EW2018-02-23
B22211FSA 38FSA 382018-03-16
B22214FSA 52FSA 522018-03-16
B22215SportSight GPSportSight GP2018-02-23
B22216HDS HI 1.54HDS HI 1.542018-02-02
B222700Single Lens BillBoard7002017-12-08
B222750Bi-Lens BillBoard7502017-12-08
B22201Optacryl 60Optacryl 602017-10-24
B22225Oxfore100Oxfore1002023-09-18
B22204Fluoroperm 92Fluoroperm 922018-03-23
B22205Fluoroperm 60Fluoroperm 602018-03-23
B22206Fluoroperm 30Fluoroperm 302018-03-23
B22207Fluoroperm 151Fluoroperm 1512018-03-23
B22208Paragon HDSParagon HDS2018-03-23
B22209Paragon HDS100Paragon HDS1002018-03-23
B22212Paragon ThinParagon Thin2018-03-23
B22217Paragon CRTParagon CRT 2021-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850085735024BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735048BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
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10850085735062BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735079BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735086BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
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10850085735215BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735239BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
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10850085735291BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735314BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735338BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735345BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735352BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735369BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735376BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735383BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21