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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceBOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS
Generic NameLens, contact (rigid gas permeable), extended wear
Regulation Number886.5916
ApplicantBAUSCH & LOMB
1400 N. GOODMAN ST.
ROCHESTER, NY 14692
PMA NumberP860022
Supplement NumberS054
Date Received01/30/2002
Decision Date05/06/2002
Product Code MWL 
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 AN ASPHERIC DESIGN FOR EXTENDED WEAR AND LABELING CHANGES FOR THE DEVICE. REQUESTED LABELING CHANGES INCLUDE: 1) CHANGE FROM THE TITLE "PATIENT INSTRUCTIONS" TO "PATIENT CARE GUIDE". 2) UPDATE THE PRESCRIPTION CAUTION STATEMENT. 3) MODIFY THE PRODUCT DESCRIPTION SECTION OF THE PACKAGE INSERT AND PROFESSIONAL FITTING AND INFORMATION GUIDE AS FOLLOWS: A) ADD THE DESCRIPTIONS FOR BOTH THE ASPHERIC DESIGN (EXTENDED AND DAILY WEAR) AND THE PREVIOUSLY APPROVED BIFOCAL LENS (DAILY WEAR ONLY) AND SPECIFY DAILY WEAR FOR THE TORIC AND BIFOCAL DESIGNS; B) REMOVE FROM THESE PRODUCT DESCRIPTION SECTIONS THE PHRASE "WITHOUT UV" BECAUSE THIS OPTION IS NO LONGER AVAILABLE; AND C) CHANGE THE COLOR NAME OF THE BLUE LENS MATERIAL FROM "DARK BLUE" TO "ELECTRIC BLUE". 4) CORRECT THE MANUFACTURER'S ADDRESS. 5) UPDATE THE WORDING OF THE UV WARNING AND CLARIFY THE EXTENDED WEAR INDICATION AS IN THE INDICATION STATED BELOW."THE BOSTON EQUALENS (ITAFLUOROFOCON A) RGP CONTACT LENS IS INDICATED FOR DAILY OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THE LENS IS INDICATED FOR EXTENDED WEAR FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00D TO +12.00D. THE LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA, ASTIGMATISM AND PRESBYOPIA) IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENS MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY."
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