PMA P860022S054
- Device
- BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S054
- Product code
- MWL
- Decision date
- 2002-05-06
- Classification
- Lens, Contact (rigid Gas Permeable), Extended Wear
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- 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."
Current openFDA PMA Record#
- Device
- BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S054
- Product code
- MWL
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Decision date
- 2002-05-06
- Decision code
- APPR
- Date received
- 2002-01-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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."