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.
 
DeviceBAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547
PMA NumberP980006
Supplement NumberS006
Date Received02/03/2005
Decision Date03/17/2005
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE TORIC DESIGN WITH AN EXTENDED WEAR INDICATION FOR UP TO 30 DAYS CONTINUOUS WEAR BETWEEN REMOVALS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB PURE VISION TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENS AND IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 5.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAYBE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +6.00 TO -9.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO -20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS.
-
-