(72 days)
Not Found
No
The summary describes rigid gas permeable contact lenses and their material properties and surface coating. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is indicated for the correction of refractive error and visual acuity, not for treating a disease or condition. While it can be prescribed for managing irregular corneal conditions, this is still primarily for visual correction rather than therapeutic intervention.
No
The device is a contact lens intended for daily wear to correct refractive errors and manage irregular corneal conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the device is a physical contact lens made from specific materials (hexafocon A and hofocon A) and treated with a surface coating. It is a tangible hardware device, 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that these are contact lenses designed to be worn on the eye for the correction of refractive errors and management of irregular corneal conditions. They are a physical device applied to the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic testing, or providing information about a disease state based on laboratory results. The performance studies focus on the physical properties of the lenses, biocompatibility, and clinical safety and effectiveness as a vision correction device.
Therefore, these contact lenses fall under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Acuity™ 100 (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.
TYRO™ 97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyonic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected only by using chemical disinfection.
Product codes (comma separated list FDA assigned to the subject device)
HOD, HQD - Note: HOD is listed on page 0 and HQD on page 3 for the same submission (K230965). Using both.
Device Description
Acuity 100™ (hexafocon A) are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from a currently marketed contact lens material, hexafocon A. comprised of a siloxanyl fluoromethacrylate copolymer (fluorosilicone acrylate monomers), tinted for visibility, and with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEC® , the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.
TYRO" -97 (hofocon A) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from currently marketed contact lens material. hofocon A. polymer of trifluoroethyl methacrylate and silicone methacrylate (fluorosilicone acrylate monomers), tinted for visibility, with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). TYRO""-97 (hofocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG® .the underlying material is encapsulated in a thin laver of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes (Cornea)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance Testing- Bench:
- The physical properties of the lenses are stable following 30 (thirty) disinfection cycles in Boston Simplus disinfection solution at ambient temperatures.
- The physicochemical and mechanical properties of the contact lenses are unchanged after the addition of Tangible™ Hydra-PEG®, with the exception of wettability (contact angle).
- The surface properties of the lens are stable following 30 (thirty) days of accelerated aging.
- Bioburden levels are below the acceptance criteria (
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 16, 2023
Acuity Polymers, Inc. Jose Chavez Director, Regulatory Affairs 1667 Lake Ave Building 59, Suite 303 Rochester, NY 14615
Re: K230965
Trade/Device Name: Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens , TYROTM-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: March 31, 2023 Received: April 5, 2023
Dear Jose Chavez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J Angelo Green -S
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230965
Device Name
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens
Indications for Use (Describe)
Acuity™ 100 (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.
TYRO™ 97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyonic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected only by using chemical disinfection.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG®
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K230965
I. SUBMITTER
| Date Prepared: | June 8th, 2023 |
|---|---|
| Name: | Acuity Polymers, Inc. |
| Address: | 1667 Lake Ave. |
| Building 59, Suite 303 | |
| Rochester, NY 14615 | |
| USA | |
| Contact Person: | Jose Chavez |
| Director, Regulatory Affairs | |
| Phone number: | (585) 458-8409 |
| Jose.Chavez@Acuitypolymers.com |
II. DEVICE
| Trade Name: | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®
Rigid Gas Permeable Contact Lens
TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid
Gas Permeable Contact Lens |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Daily wear rigid gas permeable contact lens |
| Classification Name: | Rigid gas permeable contact lens. (21 CFR§886.5916) |
| Regulatory Class: | Class II |
| Product Code: | HQD |
4
Purpose of the 510(k) Submission:
Acuity 100™ (hexafocon A) and TYRO™-97 (hofocon A) Rigid Gas Permeable Contact Lenses, cleared under 510(k) K162005, K180988, K052507 and K102154 are modified to include Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer designed to improve the wettability of the contact lenses. Specifically, Tangible™ Hydra-PEG® treated contact lenses demonstrate a measurable improvement in the contact angle compared to untreated lenses.
III,PREDICATE DEVICE
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® is substantially equivalent to predicate devices: Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens 510(k) numbers K162005 and K180988.
TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® is substantially equivalent to predicate devices: TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear, 510(k) numbers K052507 and K102154
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® are substantially equivalent to predicate device:
Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG Rigid Gas Permeable Contact Lenses, 510(k) number K183167.
IV. DEVICE DESCRIPTION
Acuity 100™ (hexafocon A) are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from a currently marketed contact lens material, hexafocon A. comprised of a siloxanyl fluoromethacrylate copolymer (fluorosilicone acrylate monomers), tinted for visibility, and with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN).
Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEC® , the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.
TYRO" -97 (hofocon A) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from currently marketed contact lens material. hofocon A. polymer of trifluoroethyl methacrylate and silicone
5
| Acuity Polymers
| 510(k) Premarket Notification | 510(k) Summary |
|---|---|
| Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® |
methacrylate (fluorosilicone acrylate monomers), tinted for visibility, with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN).
TYRO""-97 (hofocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG® .the underlying material is encapsulated in a thin laver of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.
The surface properties of: Acuity 100™ (hexafocon A), and TYRO™-97 (hofocon A) materials uncoated and coated with Tangible™ Hydra-PEG® are depicted in the following table:
| Acuity 100™ (hexafocon A) | TYRO™-97 (hofocon A) | |
|---|---|---|
| Sessile Drop | ||
| Contact Angle | Coated: $TM (1-focon A) with TranquilTM Hydro-PEG® and TYROTM 97 (1-focon A) with TranquilTM Hydro-PEG® |
Acuity 100" (hexatocon A) with Tangible " Hydra-PEG" and TYRO" -97 (hotocon A) with Tangible " Hvdra-PEG
permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected only by using chemical disinfection.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
ACUITY 100™ (hexafocon A) WITH TANGIBLE™ HYDRA-PEG®
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to Acuity 100™ (hexafocon A) uncoated lenses (primary predicate devices cleared under K162005 and K180988 in terms of the following:
-
- Proprietary contact lens material formulation and USAN
-
- Intended Use- Daily wear contact lens.
-
- Indication for Use
-
- Lens Designs and available parameters
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG (secondary Predicate device cleared under K183167) in terms of the following:
-
- USAN name
-
- Intended use- Daily wear contact lens.
-
- Indication for use- similar
-
- Tangible™ HYDRA-PEG® surface coating
TYRO™-97 (hofocon A) WITH TANGIBLE™ HYDRA-PEG®
TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to TYRO™-97 (hofocon A) uncoated lenses (primary predicate devices cleared under K052507 and K102154) in terms of the following:
-
- Proprietary contact lens material formulation and USAN
-
- Intended Use- Daily wear contact lens.
-
- Indication for Use
-
- Lens Designs and available parameters
TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG (Secondary Predicate device cleared under K183167) in terms of the following:
7
| Acuity Polymers
| 510(k) Premarket Notification | 510(k) Summary |
|---|---|
| Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™ -97 (hofocon A) with Tangible™ Hydra-PEG® |
-
- Thermoset copolymers derived from fluorosilicone acrylate monomers.
-
- Intended Use- Daily wear contact lens.
-
- Indication for use- similar
-
- Tangible™ Hydra-PEG® surface coating
The following Substantial Equivalence Matrix illustrates the production method, intended use, and material characteristics of Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses as well as the predicate devices.
| | Acuity 100™
(hexafocon A)
with Tangible™
Hydra-PEG®, | Acuity 100™
(hexafocon A) Rigid Gas
Permeable Contact Lens | TYRO™ -97
(hofocon A)
Rigid Gas
Permeable
Contact Lens | Boston XO®
(hexafocon A)
with Tangible™
Hydra-PEG | Indication for Use | Acuity 100™
(hexafocon A) with Tangible™
Hydra-PEG® Rigid Gas
Permeable Contact Lenses are
indicated for daily wear for the
correction of refractive error
(myopia, hyperopia, presbyopia
and/or astigmatism) in aphakic
and non-aphakic persons with
non-diseased eyes. The lenses
may be prescribed for daily wear
in otherwise non-diseased eyes
that require a rigid contact lens
for the management of irregular
corneal conditions such as
keratoconus, pellucid marginal
degeneration, or following
penetrating keratoplasty or
refractive (e.g., LASIK) surgery.
The lens may be disinfected
using a chemical disinfection
system only.
TYRO™-97 (hofocon A) with
Tangible™ Hydra-PEG® Rigid
Gas Permeable Contact Lens are
indicated for daily wear for the
correction of visual acuity in
non-aphakic persons with non-
diseased eyes that are myopic,
hyperopic or presbyopic and
which may exhibit corneal
astigmatism. Also, the lenses
may be prescribed in otherwise
non-diseased eyes that require a
gas permeable contact lens for
the management of irregular
corneal conditions such as
keratoconus, pellucid marginal
degeneration, or following
penetrating keratoplasty or
refractive (e.g., LASIK) surgery.
The lenses may be disinfected
only by using chemical
disinfection. | The Acuity 100™ (hexafocon
A) Rigid Gas Permeable
Contact Lenses are indicated
for daily wear for the
correction of refractive error
(myopia, hyperopia, presbyopia
and/or astigmatism) in aphakic
and non-aphakic persons with
non-diseased eyes. The lens
may be prescribed in spherical
and aspheric powers ranging
from -20.00 D to +20.00 D for
daily wear. The lenses may be
prescribed for daily wear in
otherwise non-diseased eyes
that require a rigid contact lens
for the management of irregular
corneal conditions such as
keratoconus, pellucid marginal
degeneration, or following
penetrating keratoplasty or
refractive (e.g., LASIK)
surgery.
The lens may be disinfected
using a chemical disinfection
system only.
The lenses may be stored in a
multipurpose solution
(BOSTON SIMPLUS or
Menicon Unique pH) solution
up to 30 days. | TYRO™-97 (hofocon
A) Rigid Gas
Permeable Spherical,
Aspheric, Toric and
Bifocal Contact Lens
is indicated for daily
wear for the
correction of visual
acuity in not-aphakic
persons with non-
diseased eyes that are
myopic, hyperopic or
presbyopic and which
may exhibit corneal
astigmatism.
The lenses may be
disinfected only by
using chemical
disinfection.
TYRO™-97 (hofocon
A) Rigid Gas
Permeable Contact
Lenses is indicated for
daily wear for the
correction of visual
acuity in non-aphakic
persons with non-
diseased eyes that are
myopic, hyperopic or
presbyopic and which
may exhibit corneal
astigmatism. Also, the
lenses may be
prescribed in
otherwise non-
diseased eyes that
require a gas
permeable contact
lens for the
management of
irregular corneal
conditions such as
keratoconus, pellucid
marginal
degeneration, or
following penetrating
keratoplasty or
refractive (e.g.,
LASIK) surgery.
The lenses may be
disinfected only by
using chemical
disinfection | The Boston XO®
(hexafocon A) with
Tangible™ Hydra-PEG
Contact Lens is
indicated for daily wear
for the correction of
refractive ametropia
(myopia, hyperopia,
astigmatism, and
presbyopia) in aphakic
and non aphakic persons
with non-diseased eyes.
Also, the lenses may be
prescribed in otherwise
non diseased eyes that
require a gas permeable
contact lens for the
management of irregular
corneal conditions such
as keratoconus, pellucid
marginal degeneration,
or following penetrating
keratoplasty or refractive
(e.g., LASIK) surgery.
The Boston XO®
(hexafocon A) with
Tangible™ Hydra-PEG
lens may be disinfected
using a chemical
disinfection system (not
heat) only. | |