| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | DURASOFT(R) 3 FOR EXT WEAR |
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| Generic Name | Lenses, soft contact, extended wear |
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| Regulation Number | 886.5925 |
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| Applicant | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 |
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| PMA Number | P830037 |
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| Date Received | 07/07/1983 |
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| Decision Date | 04/24/1984 |
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Withdrawal Date
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02/27/2019 |
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| Product Code |
LPM |
| Docket Number | 84M-0164 |
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| Notice Date | 05/31/1984 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE DURASOFT 3 (PHEMFILCON A) EXTENDED WEAR HYDROPHILIC CONTACT LENS. THE LENS IS INDICATED FOR UP TO 14 DAYS OF CONTINUOUS WEAR BETWEEN CLEANING AND DISINFECTION (EXTENDED WEAR) BY PERSONS WITH EYES THAT ARE NON-DISEASED, NOT-APHAKIC, HAVE NO MORE THAN 2.00 DIOPTERS (D) OF ASTIGMATISM, AND REQUIRE A SPHERICAL LENS IN THE POWER RANGE FROM -20.00 D TO +0.00 D FOR THE CORRECTION OF NEARSIGHTEDNESS (MYOPIA) OR FARSIGHTEDNESS (HYPEROPIA). THE LENS IS TO BE DISINFECTED USING EITHER A HEAT (THERMAL) OR A CHEMICAL (NOT HEAT) DISINFECTION SYSTEM. |
| Supplements: |
S053 S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012
S013 S014 S015 S016 S018 S019 S020 S021 S022 S023 S024 S025
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037
S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048
S051 S052 S054 |
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