Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceO2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP010019
Supplement NumberS003
Date Received06/08/2004
Decision Date09/27/2004
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR 1) A MODIFICATION TO THE LOTRAFILCON A MATERIAL TO MARKET LOTRAFILCON B CONTACT LENSES WITH AN INDICATION FOR UP TO 6 NIGHTS OF EXTENDED WEAR; 2) INCORPORATION OF A LIGHT BLUE HANDLING TINT, COPPER PHTHALOCYANINE, TO BOTH THE LOTRAFILCON A AND LOTRAFILCON B LENS MATERIALS; AND 3) A LABELING CHANGE FOR LOTRAFILCON A LENSES TO ALLOW FOR USE WITH ENZYMATIC CLEANERS. THE LOTRAFILCON B LENS WILL BE MARKETED UNDER THE TRADE NAME O2 OPTIX (LOTRAFILCON B) SOFT CONTACT LENSES FOR EXTENDED WEAR AND IS INDICATED FOR THE FOLLOWING: O2 OPTIX (LOTRAFILCON B) SPHERICAL 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 UP TO APPROXIMATELY 1.50 DIOPTERS (D) OF ASTIGMATISM THAT DOES NOT INTERFERE WITH VISUAL ACUITY. O2 OPTIX TORIC (LOTRAFILCON B) SPHERICAL 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 UP TO 6.00 D OR LESS OF ASTIGMATISM. O2 OPTIX PROGRESSIVE (LOTRAFILCON B) SPHERICAL 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 D OR LESS AND WHO MAY HAVE UP TO APPROXIMATELY 1.50 D OF ASTIGMATISM. O2 OPTIX PROGRESSIVE TORIC (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA, ASTIGMATISM, AND PRESBYOPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENSES MAY BE WORN BY PERSONS WHO HAVE 0.75 TO 2.75 D OF REFRACTIVE AND/OR CORNEAL ASTIGMATISM. THE LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR FOR UP TO 6 NIGHTS OF CONTINUOUS WEAR WITH REMOVAL FOR DISPOSABLE, OR CLEANING AND DISINFECTION (CHEMICAL, NOT HEAT) PRIOR TO REINSERTION, AS RECOMMENDED BY THE EYE CARE PROF.
-
-