FDA.reportPublic FDA data

PMA P890023S016

Device
HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S016
Product code
LPM
Decision date
2004-09-24
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
APPROVAL FOR A MINOR DESIGN CHANGE TO INCORPORATE THE ASPHERIC VERSION OF THE LENS; A MINOR EDGE CONFIGURATION CHANGE; AND MINOR LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR AND IS INDICATED AS FOLLOWS: HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THEY ARE ALSO INDICATED FOR EXTENDED WEAR UP TO 7 DAYS/6NIGHTS. THE EYE CARE PRACTITIONER MAY PRESCRIBE THE CONTACT LENSES FOR EITHER SINGLE USE DISPOSABLE WEAR OR FOR FREQUENT REPLACEMENT WEAR. WHEN PRESCRIBED FOR FREQUENT REPLACEMENT/ PLANNED REPLACEMENT, THE LENSES MAY BE DISINFECTED USING A CHEMICAL OR HYDROGEN PEROXIDE DISINFECTING SYSTEM. THE DEVICE HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.

Current openFDA PMA Record#

Device
HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S016
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2004-09-24
Decision code
APPR
Date received
2004-08-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A MINOR DESIGN CHANGE TO INCORPORATE THE ASPHERIC VERSION OF THE LENS; A MINOR EDGE CONFIGURATION CHANGE; AND MINOR LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR AND IS INDICATED AS FOLLOWS: HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THEY ARE ALSO INDICATED FOR EXTENDED WEAR UP TO 7 DAYS/6NIGHTS. THE EYE CARE PRACTITIONER MAY PRESCRIBE THE CONTACT LENSES FOR EITHER SINGLE USE DISPOSABLE WEAR OR FOR FREQUENT REPLACEMENT WEAR. WHEN PRESCRIBED FOR FREQUENT REPLACEMENT/ PLANNED REPLACEMENT, THE LENSES MAY BE DISINFECTED USING A CHEMICAL OR HYDROGEN PEROXIDE DISINFECTING SYSTEM. THE DEVICE HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.