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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/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.
 
DeviceFOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP010019
Date Received03/21/2001
Decision Date10/11/2001
Product Code LPM 
Docket Number 01M-0479
Notice Date 10/19/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S058 S059 S060 S061 S062 
S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 
S075 S076 S077 S078 S079 S080 S081 S083 S084 S085 
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