FDA.reportPublic FDA data

PMA P890023S011

Device
HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S011
Product code
LPM
Decision date
2002-01-16
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
APPROVAL FOR THE HYDROGENICS 60 (OCUFILCON F) UV IN-MONOMER TINT CONTACT LENS INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATIONS: SPHERICAL: HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM UP TO 2.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. TORIC: HYDROGENICS (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO -6.00 DIOPTERS. THE OVERALL POWER RANGE IS +8.00D TO -10.00D SPHERE AND PL TO -6.00D CYLINDER. THE LENS MAY BE PRESCRIBED FOR DAILY OR EXTENDED WEAR IN NOT-APHAKIC PERSONS. WHEN PRESCRIBING FOR EXTENDED WEAR, THE EYE CARE PRACTITIONER MAY RECOMMEND LENS WEAR UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION. THE EYE CARE PRACTITIONER MAY PRESCRIBE THE CONTACT LENS FOR EITHER SINGLE USE DISPOSABLE WEAR OR FOR SCHEDULED REPLACEMENT WEAR, WITH CLEANING, DISINFECTION, AND SCHEDULES REPLACEMENT. WHEN PRESCRIBING FOR SCHEDULED REPLACEMENT WEAR, THE CONTACT LENS MAY BE DISINFECTED USING A CHEMICAL (NOT HEAT) DISINFECTING SYSTEM. HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.

Current openFDA PMA Record#

Device
HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S011
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2002-01-16
Decision code
APPR
Date received
2001-07-20
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR THE HYDROGENICS 60 (OCUFILCON F) UV IN-MONOMER TINT CONTACT LENS INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATIONS: SPHERICAL: HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM UP TO 2.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. TORIC: HYDROGENICS (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO -6.00 DIOPTERS. THE OVERALL POWER RANGE IS +8.00D TO -10.00D SPHERE AND PL TO -6.00D CYLINDER. THE LENS MAY BE PRESCRIBED FOR DAILY OR EXTENDED WEAR IN NOT-APHAKIC PERSONS. WHEN PRESCRIBING FOR EXTENDED WEAR, THE EYE CARE PRACTITIONER MAY RECOMMEND LENS WEAR UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION. THE EYE CARE PRACTITIONER MAY PRESCRIBE THE CONTACT LENS FOR EITHER SINGLE USE DISPOSABLE WEAR OR FOR SCHEDULED REPLACEMENT WEAR, WITH CLEANING, DISINFECTION, AND SCHEDULES REPLACEMENT. WHEN PRESCRIBING FOR SCHEDULED REPLACEMENT WEAR, THE CONTACT LENS MAY BE DISINFECTED USING A CHEMICAL (NOT HEAT) DISINFECTING SYSTEM. HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.