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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameFOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Nameextended wear soft contact lenses
Regulation Number886.5925
ApplicantALCON LABORATORIES, INC.
PMA NumberP010019
Date Received03/21/2001
Decision Date10/11/2001
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 01M-0479
Notice Date 10/19/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the focus night and day (lotrafilcon a) soft contact lenses for extended wear. The device will be marketed with the following trade names and indications: focus night and day (lotrafilcon a) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1. 50 diopters of astigmatism. Focus night and day toric (lotrafilcon a) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia in phakic or aphakic persons with non-diseased eyes with 6. 00 diopters (d) or less of astigmatism. Focus night and day progressives (lotrafilcon a) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3. 00 diopters (d) or less and who may have up to approximately 1. 50 diopters of astigmatism. The lenses may be prescribed for extended wear for up to 30 nights of continuous wear, with removal for disposal, or cleaning and disinfection prior to reinsertion, as recommended by the eye care professional.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S014 S015 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 
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