| 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 | FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES |
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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 | P000030 |
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| Date Received | 07/18/2000 |
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| Decision Date | 10/12/2001 |
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| Product Code |
LPM |
| Docket Number | 01M-0480 |
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| Notice Date | 10/19/2001 |
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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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Approval Order Statement
APPROVAL FOR THE FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES. THE DEVICE IS INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH UP TO APPROXIMATELY 1.50 DIOPTERS OF ASTIGMATISM. THE LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR FOR 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. LENSES SHOULD BE REPLACED EVERY MONTH AND WHEN REMOVED BETWEEN REPLACEMENT TIMES MUST BE CLEANED AND DISINFECTED WITH A CHEMICAL, NOT HEAT, DISINFECTION SYSTEM BEFORE REINSERTION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 |
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