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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.
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Alcon Laboratories, Inc.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP000030
Date Received07/18/2000
Decision Date10/12/2001
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 01M-0480
Notice Date 10/19/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the focus night and day (lotrafilcon a) soft contact lenses. The device is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1. 50 diopters of astigmatism. The lenses may be prescribed for extended wear for 1 to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. Lenses should be replaced every month and when removed between replacement times must be cleaned and disinfected with a chemical, not heat, disinfection system before reinsertion.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003