FDA.reportPublic FDA data

PMA P890023S013

Device
BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR)
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S013
Product code
LPM
Decision date
2002-03-11
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
APPROVAL FOR BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS/ 6 NIGHTS). THE SPONSOR ALSO REQUESTED APPROVAL OF THE SUBJECT DEVICES TO INCLUDE A STATEMENT THAT THE UV ABSORBING CONTACT LENSES HELP TO PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATION: THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES WHICH MANIFEST MYOPIA (NEARSIGHTEDNESS), HYPEROPIA (FARSIGHTEDNESS) AND ASTIGMATIC CORRECTION LOWER THAN -2.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR. FOR EXTENDED WEAR, THE LENS MAY BE PRESCRIBED FOR UP TO 7 DAYS/6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION; OR FOR DISPOSABLE WEAR AS DIRECTED BY THE EYE CARE PRACTITIONER. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES MAY BE PRESCRIBED FOR SINGLE USE DISPOSABLE WEAR OR FOR SCHEDULED REPLACEMENT WEAR, WITH CLEANING, DISINFECTION, AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR SCHEDULED REPLACEMENT THE LENS MAY BE DISINFECTED USING A CHEMICAL (NOT HEAT) OR HYDROGEN PEROXIDE DISINFECTING SYSTEM. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.

Current openFDA PMA Record#

Device
BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR)
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S013
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2002-03-11
Decision code
APPR
Date received
2002-01-18
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS/ 6 NIGHTS). THE SPONSOR ALSO REQUESTED APPROVAL OF THE SUBJECT DEVICES TO INCLUDE A STATEMENT THAT THE UV ABSORBING CONTACT LENSES HELP TO PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATION: THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES WHICH MANIFEST MYOPIA (NEARSIGHTEDNESS), HYPEROPIA (FARSIGHTEDNESS) AND ASTIGMATIC CORRECTION LOWER THAN -2.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR. FOR EXTENDED WEAR, THE LENS MAY BE PRESCRIBED FOR UP TO 7 DAYS/6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION; OR FOR DISPOSABLE WEAR AS DIRECTED BY THE EYE CARE PRACTITIONER. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES MAY BE PRESCRIBED FOR SINGLE USE DISPOSABLE WEAR OR FOR SCHEDULED REPLACEMENT WEAR, WITH CLEANING, DISINFECTION, AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR SCHEDULED REPLACEMENT THE LENS MAY BE DISINFECTED USING A CHEMICAL (NOT HEAT) OR HYDROGEN PEROXIDE DISINFECTING SYSTEM. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.