(135 days)
Not Found
No
The summary describes a physical contact lens and its material properties, intended use, and clinical study results. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia, which are vision corrections rather than therapeutic treatments for eye diseases.
No
This device is a contact lens used for the correction of refractive errors, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of a specific material (samfilcon A) and includes physical properties and dimensions. It is a tangible hardware device.
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 Function: The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens is a medical device intended for correcting refractive errors (myopia, hyperopia, astigmatism, and presbyopia) by being placed directly on the surface of the eye. It does not analyze biological samples.
- Intended Use: The intended use clearly states its purpose is for vision correction in non-diseased eyes.
- Device Description: The description focuses on the physical properties and materials of the contact lens itself, not on any components designed for analyzing biological samples.
Therefore, this device falls under the category of a medical device for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D.
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D.
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is 46% water and 54% samfilcon A material (a siloxane copolymer with N-vinyl pyrrolidone). This lens is tinted blue with Reactive Blue Dye 246 to make them easier to see when handling.
The packaging material consists of a polypropylene blister, borate buffered saline with poloxamine and a plastic coated aluminium lid stock. The disposable blister container and the lidstock are used in the predicate device. The packaged lenses are steam sterilized in a validated autoclave. Each lens is labelled with the lens parameters, lot number and expiration date.
Lenses have the following physical properties:
Refractive Index: 1.411
Light Transmittance: 97.3%
Water Content: 46%
Specific Gravity: 1.048
Oxygen Permeability: 114 x 10-11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C (polarographic method)
The lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
Diameter: 13.5mm to 15.0mm
Center Thickness: 0.05mm to 0.75mm (varies with power)
Base Curve: 7.8mm to 9.5mm
Power Range: +20.00D to -20.00D
Cylinder Power (Toric): -0.75D to -5.00D
Cylinder Axis (Toric): 0° to 180°
Add Power (Multi-Focal): +0.75D to +5.00D
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical testing was conducted to verify substantial equivalence of the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens to the predicate, Bausch & Lomb PureVision (balafilcon A) Contact Lens. Non-clinical biocompatibility was conducted in accordance with FDA's Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994 and GLP regulation (21 CFR part 58).
Non-clinical testing performed includes:
- physiochemical per ISO 18369-4, .
- biocompatibility per ISO 10993-5, ISO 10993-10 and ISO 10993-11, .
- ocular irritation per ISO 9394, .
- stability per ISO 11987, .
- preservative uptake per ISO 11986, .
- . extractables per ISO 18369-4 and
- . solution compatibility ISO 11981.
All test results met the pre-established acceptance criteria.
The testing performed on the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens demonstrates the lens is safe and effective. Non-clinical testing included conformance to predetermined specifications. All test results verify that the device performs as expected and is substantially equivalent to the predicate device without adversely impacting safety and efficacy.
A prospective, three-month randomized clinical study utilizing adopted soft contact lens wearers was conducted. This study evaluated the safety and effectiveness of the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens. In addition, the study was performed to establish substantial equivalence to the predicate device, Bausch & Lomb PureVision (balafilcon A) Contact Lens.
The primary safety variable was biomicroscopy findings and the primary efficacy variable was visual acuity. Additional variables were tested, including refraction, keratometry and ratings of vision, comfort, and handling and "other" symptoms.
The primary safety and efficacy endpoints were achieved and no adverse events occurred during the study.
In conclusion, the results of the study demonstrated that the lens is safe and effective and is substantially equivalent to the predicate device.
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
2013
Bausch + Lomb Traditional 510(k) Premarket Notification Bausch + Lomb samfilcon A Contact Lens
510(k) SUMMARY
Submitter Information:
| Date Prepared: | August 14, 2013 |
|---|---|
| Name: | Bausch & Lomb Incorporated |
| Address: | 1400 North Goodman Street |
| Rochester, NY 14609 | |
| Contact Person: | Barbara Klube-Falso |
| Sr. Regulatory Specialist, Global Regulatory Affairs | |
| Phone Number: | (585) 338-8503 |
| (585) 338-0702 (fax) | |
| Email: | Barbara.Klube-Falso@bausch.com |
Device Information:
Trade Name:
Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens
Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism
Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
Common Name: Soft contact lens, daily wear
Device Classification: Class II (21 CFR 886.5925)
Classification Name: Daily Wear Soft (Hydrophilic) Contact Lens
Product Code: LPL, MVN
Predicate Device:
The predicate device is the
- Bausch + Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens cleared . under K122575,
- Bausch + Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens . cleared under K122575,
- Bausch + Lomb PureVision Multi-Focal (balafilcon A) Visibility Tinted Contact . Lens cleared under K050948.
1
| Bausch + Lomb | Page 2 of 5 |
|---|---|
| Traditional 510(k) Premarket Notification | SECTION 5 |
| Bausch + Lomb samfilcon A Contact Lens | 510(k) SUMMARY |
Device Description:
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is 46% water and 54% samfilcon A material (a siloxane copolymer with N-vinyl pyrrolidone). This lens is tinted blue with Reactive Blue Dye 246 to make them easier to see when handling.
The packaging material consists of a polypropylene blister, borate buffered saline with poloxamine and a plastic coated aluminium lid stock. The disposable blister container and the lidstock are used in the predicate device. The packaged lenses are steam sterilized in a validated autoclave. Each lens is labelled with the lens parameters, lot number and expiration date.
Lenses have the following physical properties:
| Refractive Index: | 1.411 |
|---|---|
| Light Transmittance: | 97.3% |
| Water Content: | 46% |
| Specific Gravity: | 1.048 |
| Oxygen Permeability: | 114 x $10^{-11}$ [cm³O₂(STP) x cm]/(sec x cm² x |
| mmHg)@35°C (polarographic method) |
The lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
| Diameter | 13.5mm to 15.0mm |
|---|---|
| Center Thickness | 0.05mm to 0.75mm (varies with power) |
| Base Curve | 7.8mm to 9.5mm |
| Power Range | +20.00D to -20.00D |
| Cylinder Power (Toric) | -0.75D to -5.00D |
| Cylinder Axis (Toric) | 0° to 180° |
| Add Power (Multi-Focal) | +0.75D to +5.00D |
2
| Bausch + Lomb | Page 3 of 5 |
|---|---|
| Traditional 510(k) Premarket Notification | SECTION 5 |
| 510(k) SUMMARY | |
| Bausch + Lomb samfilcon A Contact Lens |
Indications for Use:
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D
to -20.00D.
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D.
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.
3
| Bausch + Lomb
Traditional 510(k) Premarket Notification
Bausch + Lomb samfilcon A Contact Lens | Page 4 of 5
SECTION 5
510(k) SUMMARY |
| ------------------------------------------------------------------------------------------------------ | -------------------------------------------- |
|---|
Technological Characteristics:
The table below shows a side-by-side comparison of technological characteristics evaluated to determine substantial equivalence of the new device to the predicate Differences were evaluated during the design and development of the new device. device. Performance testing was completed and demonstrated the proposed device and predicate device are substantially equivalent and the differences do not negatively impact the safety and efficacy of the device.
| Property | Predicate Device(s)
Bausch +Lomb PureVision
(balafilcon A) Product Family
K050948 and K122575 | New Device
Bausch + Lomb (samfilcon A)
Product Family |
|-------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Intended Use | Daily Wear, Daily Disposable | Same |
| Lens Material Group | Silicone Hydrogel | Same |
| Visibility Tint | Reactive Blue 246 | Same |
| Manufacturing
Method | Cast Molded | Same |
| Lens Designs | Spherical, Toric, Multifocal | Same |
| Sterilization Method | Autoclave | Same |
| Packaging | Polypropylene Blister | Same |
| Packaging Solution | Borate Buffered Saline | Borate buffered saline with
Poloxamine |
| USAN Name | balafilcon A | samfilcon A |
| Water Content | 36% | 46% |
Summary of Non-Clinical Testing:
Non-clinical testing was conducted to verify substantial equivalence of the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens to the predicate, Bausch & Lomb PureVision (balafilcon A) Contact Lens. Non-clinical biocompatibility was conducted in accordance with FDA's Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994 and GLP regulation (21 CFR part 58).
Non-clinical testing performed includes:
- physiochemical per ISO 18369-4, .
- biocompatibility per ISO 10993-5, ISO 10993-10 and ISO 10993-11, .
- ocular irritation per ISO 9394, .
4
Bausch + Lomb Page 5 of 5 SECTION ! Traditional 510(k) Premarket Notification 510(k) SUMMAR Bausch + Lomb samfilcon A Contact Lens
- stability per ISO 11987, .
- preservative uptake per ISO 11986, .
- . extractables per ISO 18369-4 and
- . solution compatibility ISO 11981.
All test results met the pre-established acceptance criteria.
The testing performed on the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens demonstrates the lens is safe and effective. Non-clinical testing included conformance to predetermined specifications. All test results verify that the device performs as expected and is substantially equivalent to the predicate device without adversely impacting safety and efficacy.
Summary of Clinical Performance Data:
A prospective, three-month randomized clinical study utilizing adopted soft contact lens wearers was conducted. This study evaluated the safety and effectiveness of the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens. In addition, the study was performed to establish substantial equivalence to the predicate device, Bausch & Lomb PureVision (balafilcon A) Contact Lens.
The primary safety variable was biomicroscopy findings and the primary efficacy variable was visual acuity. Additional variables were tested, including refraction, keratometry and ratings of vision, comfort, and handling and "other" symptoms.
The primary safety and efficacy endpoints were achieved and no adverse events occurred during the study.
In conclusion, the results of the study demonstrated that the lens is safe and effective and is substantially equivalent to the predicate device.
Risks and Benefits:
The risks of the subject device are the same as those found in the predicate device. The benefits to the patient are the same as those in the predicate device and outweigh the risks when worn according to instructions.
Substantial Equivalence Conclusion:
The cumulative results of the non-clinical testing sponsored by Bausch + Lomb demonstrate that the safety, efficacy and performance of Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens are substantially equivalent to the predicate lenses and similar to other daily wear soft contact lenses on the market.
Any differences that may exist between the samfilcon A contact lens and other silicone hydrogels do not adversely affect the safety and efficacy of the Bausch + Lomb (samfilcon A) Contact Lens when worn according to instructions.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
September 11, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-(1609 Silver Spring, MD 20993-0002
Bausch + Lomb % Ms. Barbara Klube-Falso Sr. Specialist. Global Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
Re: K131208
Trade/Device Name: Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfileon A) Soft (hydrophilic) Contact Lens for Astigmatism, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbropia Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 15. 2013 Received: August 19. 2013
Dear Ms. Klube-Falso:
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.
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.
6
Page 2 - Ms. Barbara Klube-Falso
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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for 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
7
Indications for Use
510(k) Number (if known):
Device Name: Bausch + Lomb samfilcon A Soft (hydrophilic) Contact Lens; Bausch + Lomb samfilcon A Soft (hydrophilic) Contact Lens for Astigmatism; Bausch + Lomb samfilcon A Soft (hydrophilic) Contact Lens for Presbyopia.
Indications For Use:
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D.
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D.
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
Page 1 of 2
8
DISPOSABLE WEAR
When prescribed for Disposable Wear, the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Marc W. Robbov -5
-04-00, 17 12:31:15
03:50 PM (Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K131208
0392796
Digitally signed by Marc W.
DN c=US, o=U.S. Government, DUMHS. OU=FDA QU=People
cn=Marc W. Robboy -5.
0.9.2342.19200300.100.1.1=130
Page 2 of 2