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.
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.
Device | BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR) |
Classification Name | Lenses, Soft Contact, Extended Wear |
Generic Name | Lenses, Soft Contact, Extended Wear |
Applicant | THE COOPER COMPANIES |
Date Received | 2002-01-18 |
Decision Date | 2002-03-11 |
PMA | P890023 |
Supplement | S013 |
Product Code | LPM |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | THE COOPER COMPANIES 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588 |
Supplement Number | Date | Supplement Type |
---|---|---|
P890023 | Original Filing | |
S049 | 2022-08-29 | 30-day Notice |
S048 | 2022-04-26 | 30-day Notice |
S047 | 2020-09-25 | 30-day Notice |
S046 | ||
S045 | 2020-08-24 | 30-day Notice |
S044 | 2020-08-20 | 30-day Notice |
S043 | 2020-08-03 | 30-day Notice |
S042 | 2020-01-15 | 30-day Notice |
S041 | ||
S040 | 2019-12-03 | 30-day Notice |
S039 | 2019-10-15 | 30-day Notice |
S038 | 2019-08-13 | 30-day Notice |
S037 | 2019-02-26 | 30-day Notice |
S036 | 2019-02-08 | 30-day Notice |
S035 | 2018-08-09 | Normal 180 Day Track No User Fee |
S034 | 2018-06-18 | Real-time Process |
S033 | 2018-06-15 | Real-time Process |
S032 | 2018-04-05 | Normal 180 Day Track No User Fee |
S031 | 2018-03-16 | 135 Review Track For 30-day Notice |
S030 | 2018-01-16 | 135 Review Track For 30-day Notice |
S029 | 2017-10-24 | 30-day Notice |
S028 | 2017-08-04 | Real-time Process |
S027 | 2017-01-30 | 30-day Notice |
S026 | 2017-01-08 | 30-day Notice |
S025 | 2016-04-13 | Normal 180 Day Track No User Fee |
S024 | 2015-12-22 | 30-day Notice |
S023 | 2015-07-02 | 30-day Notice |
S022 | 2014-09-08 | Normal 180 Day Track No User Fee |
S021 | 2013-11-13 | 135 Review Track For 30-day Notice |
S020 | 2013-11-12 | 30-day Notice |
S019 | 2013-07-22 | 30-day Notice |
S018 | 2011-11-01 | 30-day Notice |
S017 | 2010-04-26 | 135 Review Track For 30-day Notice |
S016 | 2004-08-18 | Real-time Process |
S015 | 2004-07-02 | Normal 180 Day Track No User Fee |
S014 | 2003-12-22 | Normal 180 Day Track No User Fee |
S013 | 2002-01-18 | Normal 180 Day Track |
S012 | ||
S011 | 2001-07-20 | Normal 180 Day Track |
S010 | ||
S009 | 1999-09-17 | Normal 180 Day Track |
S008 | 1999-07-29 | 30-day Notice |
S007 | 1999-04-20 | Real-time Process |
S006 | 1996-02-13 | Normal 180 Day Track |
S005 | 1995-10-23 | Normal 180 Day Track |
S004 | 1995-10-02 | Normal 180 Day Track |
S003 | 1995-09-29 | Normal 180 Day Track |
S002 | 1993-05-24 | Normal 180 Day Track |
S001 | 1990-10-31 | Normal 180 Day Track |