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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePUREVISION 2/PUREVISION 2 MULTI-FOCAL/PUREVISION 2 TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namebalafilcon a visibility tinted contact lens
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP980006
Supplement NumberS012
Date Received04/02/2008
Decision Date05/30/2008
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for decreasing the center thickness of the purevision lens and adding 0. 3 wt% hydroxypropyl methylcellulose to the packing solution. The device, as modified, will be marketed under the trade name purevision 2 visibility tinted contact lenses and is indicated for the following approved indications for use: vision correction the bausch & lomb purevision 2 (balafilcon a) visibility tinted contact lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. 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. The lens may be prescribed for frequent/planned replacement wear or disposable wear in spherical powers ranging from +8. 00d to ?20. 00d when prescribed for up to 30 days of extended wear and from +20. 00d to ?20. 00d for daily wear or extended wear up to 7 days. The bausch & lomb purevision 2 multi-focal (balafilcon a) visibility tinted contact lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. 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 up to 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 +6. 00d to -18. 00d when prescribed for up to 30 days of extended wear and from +20. 00d to ?20. 00d for daily wear or extended wear up to 7 days with add powers ranging from +0. 75d to +5. 00d. (see approval order for additional information).
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