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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 NameSOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES
Classification Namelenses, soft contact, daily wear
Generic Namealphafilcon a visibility tinted contact lenses
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP960022
Supplement NumberS003
Date Received03/03/2003
Decision Date04/04/2003
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a toric design with an extended wear indication from 1 to 7 days between removals for the above referenced device. The device, as modified, will be marketed under the trade name bausch & lomb soflens66 toric (alphafilcona) visibility tinted contact lenses and is indicated for extended wear from 1 to 7 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) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5. 00 diopters (d) 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. 00 d to -9. 00d when prescribed for use to 7 days of extended wear.
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