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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 S. Fwy.
Fort Worth, TX 76134
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
Predetermined Change Control Plan AuthorizedNo
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: S025 S020  S021 S022 S023 S024 S026 S017 S003 S010 S011 
S009 S007 S001 S051 S052 S054 S002 S008 S013 S014 S018 S019 
S005 S015 S050 S055 S053 S066 S067 S068 S056 S058 S059 S071 
S077 S083 S079 S080 S081 S085 S065 S062 S060 S061 S063 S064 
S069 S072 S073 S075 S086 S006 S004 S027 S034 S040 S042 S043 
S037 S030 S031 S032 S036 S038 S028 S029 S041 S033 S039 S074 
S070 S076 S078 S035 S087 S084 S044 S045 S046 S047 S048 S049 
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