| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Bausch + Lomb Ultra (samfilcon A) Contact Lenses |
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| Generic Name | Lenses, soft contact, extended wear |
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| Regulation Number | 886.5925 |
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| Applicant | Bausch and Lomb, Inc.
1400 North Goodman Street
Rochester, NY 14609 |
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| PMA Number | P170035 |
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| Date Received | 11/01/2017 |
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| Decision Date | 04/30/2018 |
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| Product Code |
LPM |
| Docket Number | 18M-1791 |
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| Notice Date | 05/14/2018 |
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| Advisory Committee |
Ophthalmic |
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| Clinical Trials | NCT02939950
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the Bausch + Lomb Ultra (samfilcon A) Contact Lenses. These devices are indicated for:Single Vision Spherical (SVS) Vision CorrectionThe BAUSCH + LOMB ULTRA (samfilcon A) Contact Lens is indicated for extended wear for up to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated 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.Presbyopia Vision CorrectionThe BAUSCH + LOMB ULTRA (samfilcon A) Contact Lens for Presbyopia is indicated for extended wear for up to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia 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 add powers ranging from +0.75D to +5.00D. Astigmatism Vision CorrectionThe BAUSCH + LOMB ULTRA (samfilcon A) Contact Lens for Astigmatism is indicated for extended wear for up to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism up to 5.00 diopters. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013
S014 S015 S016 S017 |
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