(167 days)
Not Found
No
The document describes contact lenses and their material properties, intended use, and performance studies, none of which mention AI or ML.
Yes
The device is indicated for the correction of visual acuity in persons with certain eye conditions and may provide improved comfort for those experiencing mild discomfort or symptoms related to dryness due to specific tear deficiencies. This aligns with a therapeutic purpose by addressing visual impairment and alleviating symptoms.
No
Explanation: The device, Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses, is indicated for correction of visual acuity and improved comfort. It does not provide information about a patient's health status or diagnose any condition.
No
The device is a physical contact lens made of a specific material (omafilcon A) and designed for insertion into the eye. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity in individuals with specific refractive errors (myopia, hyperopia, astigmatism, presbyopia) and to potentially improve comfort for those experiencing mild dryness. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The device is a contact lens, which is a physical object placed on the eye to alter light refraction. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to identify, diagnose, or monitor a disease or condition through the analysis of in vitro samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic in powers from -20.00, possess astigmatism to -5.75 diopters, and are presbyopic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only),
Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 that are myopic or hyperopic and are presbyonic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic and hyperopic in powers from -20.00 to +20.00 diopters and astigmatism corrections to -5.75 diopters. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The Proclear Toric XR, Multifocal XR and Multifocal Toric (omafilcon A) Contact Lenses are made from a material containing 59% water and 41% omafilcon A, a polymer of 2-hydroxy-ethylmethacrylate and 2methacryloyloxyethyl phosphorylcholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge for visibility purposes with Vat Blue 6.
Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lens is a back surface toric.
Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The Proclear Multifocal XR is designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lens front surface is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic.
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
Daily wear replacement schedules may vary from patient to patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the 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)
A series of in-vitro and in-vivo preclincal toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the contact lens. All tests were conducted in accordance with the GLP regulation (21 CFR Part 56) or according to valid scientific protocols.
Tests performed:
- Cytotoxicity Test ISO 10993 - 5: 1999: Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- ISO Ocular Irritation ISO 10993 - 10:2002: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed Hypersensitivity
- Systemic Toxicity Study ISO 10993 - 11: 1996: Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity.
- ISO Contact Lens 22 Day Ocular Irritation Study ISO 9394 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products The determination of Biocompatibility by Ocular Study with Rabbit Eyes.
- Total Extractables, Water content, Dk, Light Transmittance, refractive index tested per ISO 18369-4:2006 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials: section 4.2
Key Results:
The results for the non-clinical testing demonstrate:
- The lens material and lens material extracts are non-toxic, non-irritating under the experimental conditions.
- The lens physical and material properties are consistent with currently marketed soft contact lenses.
- No evidence of unsafe amounts of residue in the extractables.
- Physicochemical testing of the subject lenses demonstrated equivalency to the predicate devices.
- Lens remains sterile and stable in the package, for the established shelf life.
- The technical characteristics, manufacturing and sterilization process of the subject lens are equivalent to omafilcon A soft contact lenses currently marketed by CooperVision, therefore no clinical data is required.
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.
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
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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/1 description: The image shows a black and white image of a circular object. The object is mostly black, with some white spots. The object appears to be a fruit or vegetable.
6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588
T 925 621 2480
F 925 621 2487 www.coopervision.com JUN 2 9 2011
CooperVision"
CooperVision: 510(k) Summary (as required by section 807.92(c)). K110099
| Submitted By: | CooperVision Inc.
6150 Stoneridge Mall Road, Suite 370
Pleasanton, CA 94588 |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Sarah Harrington MS, MBA
Regulatory Affairs
925 621-2458: Phone
866 491-7424; FAX
sharrington@coopervision.com |
| Date Prepared: | May 26 2011 |
| Trade Name: | Proclear Toric XR (omafilcon A) Soft (hydrophilic) Contact Lens
Proclear Multifocal XR (omafilcon A) Soft (hydrophilic) Contact Lens
Proclear Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact Lens |
| Common Name: | Soft Contact Lens |
| Classification: | Lenses, Soft Contact, Daily Wear
Class II: LPL, 21 CFR 886.5925 |
1
510(k) Summary
Proclear Toric XR, Multifocal and Multifocal XR Daily Wear Soft Contact Lenses
Substantially Equivalent Devices:
Proclear Toric XR, Proclear Multifocal XR and Proclear Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear, K081865.
Proclear XC and Proclear 1 day (omafilcon A) Hydrophilic Contact Lenses for Daily Wear, K061948.
Device
Description:
The Proclear Toric XR, Multifocal XR and Multifocal Toric (omafilcon A) Contact Lenses are made from a material containing 59% water and 41% omafilcon A, a polymer of 2-hydroxy-ethylmethacrylate and 2methacryloyloxyethyl phosphorylcholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge for visibility purposes with Vat Blue 6.
Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lens is a back surface toric.
Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The Proclear Multifocal XR is designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lens front surface is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic.
Indication for Use:
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic or hyperopic in powers from -20.00 to +20.00, possess astigmatism to -5.75 diopters or less, and are presbyopic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes in powers from -20.00 to +20.00 that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
2
CooperVision K110099
--..
510(k) Summary
Proclear Toric XR, Multifocal and Multifocal XR Daily Wear Soft Contact Lenses
Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are Indication for Use indicated for daily wear for the correction of visual acuity in aphakic and (continued) not-aphakic persons with non-diseased eyes that are myopic or hyperopic in powers from -20.00 to +20.00 diopters and astigmatism corrections to -5.75 diopters. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non- Sjogren's only).
Daily wear replacement schedules may vary from patient to patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
Technological The technological characteristics of the subject lens and the predicate lenses Characteristics are compared in the following tables. The Subject device has the same technological characteristics (i.e., design, material, package, parameters) as the predicate devices.
| Material Comparison | |||
|---|---|---|---|
| Subject Device | Predicate | ||
| Device | Predicate | ||
| Device | |||
| Product name | Proclear Toric XR | ||
| Proclear | |||
| Multifocal XR | |||
| Proclear | |||
| Multifocal Toric | Proclear Toric XR | ||
| Proclear | |||
| Multifocal XR | |||
| Proclear | |||
| Multifocal Toric | Proclear XC | ||
| Proclear 1 day | |||
| Material USAN | |||
| Name | Omafilcon A | Omafilcon A | Omafilcon A |
| 510(k) number | This submission | K081865 | K061948 |
| FDA Category | |||
| (Group) | Group II Non-lonic | ||
| High Water | Group II Non-lonic | ||
| High Water | Group II Non-Ionic | ||
| High Water | |||
| Manufacturing | |||
| method | Finished Inside | ||
| Polymerization | |||
| System II | Finished Inside | ||
| Polymerization | |||
| System II | Cast molded | ||
| Curing | Thermal Cure | UV Cure | Thermal cure |
| Sterilization | Moist Heat (steam) in | ||
| validated Autoclave | Moist Heat (steam) | ||
| in validated | |||
| Autoclave | Moist Heat (steam) | ||
| in validated | |||
| Autoclave | |||
| Packaging | Blister Pack | Blister Pack | Blister Pack |
| Visibility tint | VAT Blue 6 | VAT Blue 6 | VAT Blue 6 |
3
CooperVision K110099
510(k) Summary
| Parameter Comparison | |||
|---|---|---|---|
| Subject Device | Predicate | ||
| Device | Predicate | ||
| Device | |||
| Product name | Proclear Toric XR | Proclear Toric XR | Proclear XC |
| Proclear | |||
| Multifocal XR | Proclear | ||
| Multifocal XR | Proclear 1 day | ||
| Proclear | |||
| Multifocal Toric | Proclear | ||
| Multifocal Toric | |||
| Water Content | 59% ± 2% | 59% ± 2% | 60% ± 2% |
| Refractive | |||
| Index | 1.395 ± 0.005 | 1.40 | 1.40 |
| Oxygen | |||
| Permeability x | |||
| 10-11 | 21.05 | 21.05 | 21.00 |
| Light | |||
| Transmission | >90% | >90% | >90% |
| Base Curve | 8.0 to .9.3 mm | 8.0 to .9.3 mm | 8.0 to .9.5 mm |
| Diameter | 13.6 to 15.2 mm | 13.6 to 15.2 mm | 13.0 to 15.5 mm |
| Power | -20.00 to +20.00 | -20.00 to +20.00 | -20.00 to +20.00 |
Proclear Toric XR, Multifocal and Multifocal XR Daily Wear Soft Contact Lenses
Non-Clinical Testing
A series of in-vitro and in-vivo preclincal toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the contact lens. All tests were conducted in accordance with the GLP regulation (21 CFR Part 56) or according to valid scientific protocols.
| Test | Acceptance Criteria | Result | |
|---|---|---|---|
| Cytotoxicity Test ISO 10993 - 5: | |||
| 1999: Biological Evaluation of | |||
| Medical Devices - Part 5: Tests for | |||
| In Vitro Cytotoxicity | All 3 monolayers exposed to | ||
| the test article show no grade | |||
| greater than grade 2 (reactivity | |||
| mild) | Pass | ||
| ISO Ocular Irritation | |||
| ISO 10993 - 10:2002: Biological | |||
| Evaluation of Medical Devices - Part | |||
| 10: Tests for Irritation and Delayed | |||
| Hypersensitivity | Test extract shows no | ||
| significant irritation over the | |||
| reagent control during the | |||
| observation period. | Pass | ||
| Systemic Toxicity Study | |||
| ISO 10993 - 11: 1996: Biological | |||
| Evaluation of Medical Devices - Part | |||
| 11: Tests for Systemic Toxicity. | During the observation period, | ||
| none of the animals treated | |||
| with the individual test extract | |||
| exhibit a significantly greater | |||
| reaction that the control | |||
| animals. | Pass | ||
| (continued) | Test | Acceptance Criteria | Result |
| ISO Contact Lens 22 Day Ocular | |||
| Irritation Study | |||
| ISO 9394 Ophthalmic Optics - Contact | |||
| Lenses and Contact Lens Care Products | |||
| The determination of Biocompatibility | Scores from macroscopic | ||
| and microscopic ocular | |||
| examinations equivalent | |||
| between test and control | |||
| eyes. | Pass | ||
| by Ocular Study with Rabbit Eyes. | |||
| Total Extractables , Water content, Dk, | |||
| Light Transmittance, refractive index | |||
| tested per ISO 18369-4:2006 | |||
| Ophthalmic optics - Contact lenses - | |||
| Part 4: Physicochemical properties of | |||
| contact lens materials: | |||
| section 4.2 | Equivalent to predicate | ||
| lens | Pass | ||
| The results for the non-clinical testing demonstrate: | |||
| · The lens material and lens material extracts are non-toxic, non-irritating | |||
| under the experimental conditions. | |||
| · The lens physical and material properties are consistent with currently | |||
| marketed soft contact lenses. | |||
| · No evidence of unsafe amounts of residue in the extractables. | |||
| · Physicochemical testing of the subject lenses demonstrated equivalency to | |||
| the predicate devices. | |||
| Clinical | · Lens remains sterile and stable in the package, for the established shelf life. | ||
| The technical characteristics, manufacturing and sterilization process of the subject | |||
| lens are equivalent to omafilcon A soft contact lenses currently marketed by | |||
| CooperVision, therefore no clinical data is required. | |||
| Conclusion Drawn from Studies: | |||
| Validity of | |||
| Scientific | |||
| Data | Contract laboratories under Good Manufacturing Practice regulations conducted | ||
| toxicological and microbiology studies. | |||
| Chemistry, shelf-life and leachablility studies were conducted by CooperVision | |||
| and followed scientific protocols. The data were determined to be scientifically | |||
| valid under 21 CFR 860.7 | |||
| Substantial | |||
| Equivalence | Information presented in this Premarket Notification establishes that the | ||
| Cooper Vision (omafilcon A) Proclear Toric XR, Proclear Multifocal and Proclear | |||
| Multifocal XR contact lens is as safe and effective as the predicate devices when | |||
| used in accordance with the labeled directions for use and for the requested | |||
| indications. | |||
| Risk and | The risks of the subject lens are the same as those normally attributed to the | ||
| wearing of soft (hydrophilic) contact lenses on a daily wear basis. The benefits to | |||
| the patient are the same as those for other soft (hydrophilic) contact lenses. |
4
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
510(k) Summary
Proclear Toric XR, Multifocal and Multifocal XR
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CooperVision Inc. c/o Ms. Lisa Hahn Global Regulatory Affairs Manager 6150 Stoneridge Mall Road, Suite 370 Pleasanton, CA 94588
JUN 2 9 2011
Re: K110099
Trade/Device Name:
Proclear Toric XR (Omafilcon A) Soft (hydrophilic) Contact Lens Proclear Multifocal XR (Omafilcon A) Soft (hydrophilic) Contact Lens Proclear Multifocal Toric (Omafilcon A) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: May 27, 2011 Received: May 31, 2011
Dear Ms. Hahn:
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. 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.
6
Page 2 - Ms. Lisa Hahn
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); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersQffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for
MR.
DR.
REV.
GEN.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Goper Visiona: SEE BEYOND THE ORDINAR
Traditional 510(k)
Proclear Toric XR, Multifocal and Multifocal XR Daily Wear Soft Contact Lenses
Indications for Use
510(k) Number (if known):
Device Name: Proclear Toric XR, Multifocal XR and Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
Indications for Use:
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves that are myopic or hyperopic in powers from -20.00, possess astigmatism to -5.75 diopters, and are presbyopic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only),
Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 that are myopic or hyperopic and are presbyonic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic and hyperopic in powers from -20.00 to +20.00 diopters and astigmatism corrections to -5.75 diopters. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
| Prescription Use: YES
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| ------------------------------------------------------ | -------- | ------------------------------------------------ |
|---|
Please Do Not Write Below this line-Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
Page 1 of 1
510(k) Number_K110099