(55 days)
Boston® XO* (chexafocon A), Boston EO® (enflufocon EO® (enflufocon B), Boston ES* (enflufocon A)
Not Found
No
The document describes rigid gas permeable contact lenses and their materials, indications for use, and predicate devices. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes.
The device is indicated for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery, which are therapeutic uses.
No
Explanation: The device described is a contact lens used for vision correction and management of corneal conditions, not for diagnosing diseases or conditions. Its indicated uses are therapeutic and corrective.
No
The device description clearly states that the device is a physical contact lens manufactured from specific materials. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that these are rigid gas permeable contact lenses. Their intended use is for the correction of visual acuity and management of irregular corneal conditions. This involves direct interaction with the eye for therapeutic and corrective purposes, not for analyzing biological samples.
The document describes a medical device used for vision correction and corneal management, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
FluoroPerm® 92
FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear I horor chil. 92 ngla ga permission between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphabic persons with nondiseased eyes that are nearsighted (myopic), farsighted (byperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal leases are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 92 contact lenses are indicated for management of irregular corneal conditions such as kerator ones, pellucid marginal degeneration, or following penctrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
FluoroPerm® 60
FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear I tobior and out from 1 to 7 days between removals for cleaning and disinfection as recommonded by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact leases are indicated for daily wear only.
FluoroPerm® 60 rigid gas permeable spheric and bifocal contact leases are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (byperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfece with visual acuity. FivoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 60 contact leases are indicated for management of irregular comcal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoriasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Paragon HDS®
Paragon HDS® rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the cye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
Paragon HDS rigid gas permeable spherical, asphenc and bifocal contact lenses are indicated for the correction of visual aculty in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS tone contact leases are indicated to correct astigmatism of up to 6.00 diopters. Faragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon HDS contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratotorny, or LASIK surgeryin otherwise nondiseased eyes.
FluoroPerm® 30
FluoroPerm® 30 rigid gas permeable contact leases are indicated for daily wear as recommended by the eye care practitioner.
FluoroPerm* 30 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up 10 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up 10 6.00 diopters. FluoroPerm* 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 30 contact lenses are indicated for management of irregular comeal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Paragon Thin™
Paragon Thin " rigid gas permeable contact lenses are indicated for daily wear as recommended by the eve care practitioner.
Paragon Thin rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased tyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comes astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" witc contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin bifocal lenses are indicated to treat presbyopia up 10 +4.00 D add power.
Paragon Thin" contact lenses are indicated for management of iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
FluoroPerm® 151
FluoroPerm® 151 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerme 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
FluoroPerm 151 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased cycs that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPenn® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopers. FluoroPerm 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm 151 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Paragon HDS 100
Paragon HDS 100 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS 100 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
Paragon HDS 100 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual scuity in not-aphakic persons with nondiseased eves that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diovers that docs not interfere with visual acuity. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon HDS 100 contact leases are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following peactrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
FluoroPerm® 92, FluoroPerm® 60, Paragon HDS*, FluoroPerm* 30, Paragon Thin"*, and FluoroPerm® 151, and Paragon HDS® 100 lenses are available as lath cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; pastufocon A (FluoroPerm" 02), pallufocon B (FluoroPerm) 60, Paragon HDS®), patlufocon C (Fluorosco (Film The Paragon Time), and Poly San Poly San Parised Bron fluorosilicone acrylate monomers.
The lenses may be tinted to offer a handling and for locating the lens. The tinted lenses contain one or more of the following approved color additives: D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17.
The lenses may be available with an ultraviolet absorber (not in all colors and materials). The ultraviolet absorber, Uvinul D-49, has been integrated as an additive within the polymer matrix, blocking up to 97% of light below 380 nm. The UV absorber is 2.2'-dihydroxy-4,4'-dimethoxybenzophenone.
The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspherical curves peripheral to the base curve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye care practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Boston® XO* (chexafocon A), Boston EO® (enflufocon EO® (enflufocon B), Boston ES* (enflufocon A)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "U.S. Department of Health & Human Services" is arranged in a circle around the eagle. The logo is black and white.
MAY - 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Paragon Vision Sciences William E. Mevers, Ph.D. Vice President, Science & Technology 947 East Impala Mesa, AZ 85204-6619
Re: K070637
FluoroPerm® 30 and Paragon Thin™ (paflufocon C); Trade/Device Name: FluoroPerm® 60 and Paragon HDS® (paflufocon B): FluoroPerm® 92 (paflufocon A); and, FluoroPerm® 151 and Paragon HDS® 100 (paflufocon D) RGP Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lenses Regulatory Class: Class II Product Code: HQD Dated: March 5. 2007 Received: March 7, 2007
Dear Dr. Meyers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Dr. William Meyers
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address (car) supply industr. Support inationali.
Sincerely yours,
M.B. Egclehner SiwD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use
510(k) Number (if known):
Device Name:
FluoroPerm® 92 (paflufocon A) rigid gas permeable contact lenses FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses Paragon HDS® (paflufocon B) rigid gas permeable contact lenses FluoroPerm 30 (paflufocon C) rigid gas permeable contact lenses FluoroPerm® 151 (paflufocou D) rigid gas permeable contact lenses Paragon HDS® 100 (paflufocon D) rigid gas permeable contact lenses
Indications For Use:
FluoroPerm® 92
FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear I horor chil. 92 ngla ga permission between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphabic persons with nondiseased eyes that are nearsighted (myopic), farsighted (byperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal leases are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 92 contact lenses are indicated for management of irregular corneal conditions such as kerator ones, pellucid marginal degeneration, or following penctrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
FluoroPerm® 60
FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear I tobior and out from 1 to 7 days between removals for cleaning and disinfection as recommonded by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact leases are indicated for daily wear only.
FluoroPerm® 60 rigid gas permeable spheric and bifocal contact leases are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (byperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfece with visual acuity. FivoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 60 contact leases are indicated for management of irregular comcal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoriasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Page 1 of 3
3
Paragon HDS40
Paragon HDS® rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the cye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
Paragon HDS rigid gas permeable spherical, asphenc and bifocal contact lenses are indicated for the correction of visual aculty in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS tone contact leases are indicated to correct astigmatism of up to 6.00 diopters. Faragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon HDS contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotorny, or LASIK surgeryin otherwise nondiseased eyes.
FluoroPerm® 30
FluoroPerm® 30 rigid gas permeable contact leases are indicated for daily wear as recommended by the eye care practitioner.
FluoroPerm* 30 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up 10 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up 10 6.00 diopters. FluoroPerm* 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 30 contact lenses are indicated for management of irregular comeal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Paragon Thin"
Paragon Thin " rigid gas permeable contact lenses are indicated for daily wear as recommended by the eve care practitioner.
Paragon Thin rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased tyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comes astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" witc contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin bifocal lenses are indicated to treat presbyopia up 10 +4.00 D add power.
Paragon Thin" contact lenses are indicated for management of iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Page 2 of 3
4
FluoroPerm® 151
FluoroPerm® 151 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerme 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
FluoroPerm 151 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased cycs that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPenn® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopers. FluoroPerm 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm 151 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Paragon HDS 100
Paragon HDS 100 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS 100 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
Paragon HDS 100 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual scuity in not-aphakic persons with nondiseased eves that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diovers that docs not interfere with visual acuity. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon HDS 100 contact leases are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following peactrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Prescription Use X (Part 21 CFR 801 Sub) bart D)
Over -
(2) CFR
Over - the - Counter Use (2) CFR 801 Subpan C).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marc Roblez
0
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
Page 3 of 3
umbal
5
510(k) Summary of Safetv and Effectiveness
MAY - 1 2007
Submitter Information
Paragon Vision Sciences 947 E. Impala Ave. Mesa, AZ 85204
Contact Person:
William Meyers PhD Vice President, Science & Technology
Email: wemevers@MSN.com Phone: 480 507 7606
Device Name
FluoroPerm® 92 (patlufocon A) rigid gas permeable contact lenses FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses Paragon HDS (paflufocon B) rigid gas permeable contact lenses FluoroPerm 30 {paflufocon C) rigid gas permeable contact lenses " (paflufocon C) rigid gas permeable contact lenses Paragon Thin FluoroPerm 151 (paflufocon D) rigid gas permeable contact lenses Paragon HDS* 100 (paflufocon D) rigid gas permeable contact lenses
Reason for Submission
Expanded Indication
Predicate Devices
Classification Name: rigid gas permeable (hydrophobic) contact lens
Proprietary Names: Boston® XO* (chexafocon A),
Boston EO® (enflufocon EO® (enflufocon B)
Boston ES* (enflufocon A)
Description of the device:
FluoroPerm® 92, FluoroPerm® 60, Paragon HDS*, FluoroPerm* 30, Paragon Thin"*, and FluoroPerm® 151, and Paragon HDS® 100 lenses are available as lath cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; pastufocon A (FluoroPerm" 02), pallufocon B (FluoroPerm) 60, Paragon HDS®), patlufocon C (Fluorosco (Film The Paragon Time), and Poly San Poly San Parised Bron fluorosilicone acrylate monomers.
The lenses may be tinted to offer a handling and for locating the lens. The tinted lenses contain one or more of the following approved color additives: D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17.
The lenses may be available with an ultraviolet absorber (not in all colors and materials). The ultraviolet absorber, Uvinul D-49, has been integrated as an additive within the polymer matrix, blocking up to 97% of light below 380 nm. The UV absorber is 2.2'-dihydroxy-4,4'-dimethoxybenzophenone.
The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspherical curves peripheral to the base curve.