Duns Number:028594987
Device Description: Optacryl® 60 (kolfocon A) rigid gas permeable contact lenses for daily wear are available 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.
Catalog Number
-
Brand Name
Optacryl 60
Version/Model Number
Optacryl 60
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQD
Product Code Name
Lens, Contact (Other Material) - Daily
Public Device Record Key
99ecc4f4-eba0-48bc-8648-303551e10cf0
Public Version Date
March 23, 2021
Public Version Number
3
DI Record Publish Date
October 24, 2017
Package DI Number
B222010
Quantity per Package
1
Contains DI Package
B22201
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
vial
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |
| 3 | A medical device with high risk that requires premarket approval | 6 |