| Note: 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. |
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| Device | FOCUS(R) & NEWVUES(R) 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 | P820021 |
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| Supplement Number | S029 |
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| Date Received | 05/10/1996 |
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| Decision Date | 09/25/1996 |
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Withdrawal Date
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08/28/2019 |
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| Product Code |
LPM |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR REVISED LABELING (I.E., PACKAGE INSERT, PRACTITIONER FITTING GUIDE, AND SEPARATE PATIENT INFORMATION BOOKLETS FOR LENSES PRESCRIBED FOR FREQUENT REPLACEMENT WEAR (FOCUS, FOCUS TORIC, AND NEWVUES (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES) AND DISPOSABLE WEAR (NEWVUES (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES). REVISIONS INCLUDED (1)MERGING PLANNED REPLACEMENT AND DISPOSABLE WEARING SCHEDULES FOR THE LENSESE INTO ONE PACKAGE INSERT AND DIRECTING THE PACKAGE ISERT TO THE EYECARE PRACTITIONER, (2)WRITING SEPARATE PATIENT INSTRUCTIONS FOR LENSES PRESCRIBED FOR DISPOSABLE AND FREQUENT REPLACEMENT WEAR, (3)UPDATING THE PROFESSIONAL FITTING GUIDE FOR CONSISTENCY WITH OTHER LABELING ITEMS, AND (4)BRINGING THE LABELING UP-TO-DATE WITH FDA'S CURRENT RECOMMENDATIONS IN AN EFFORT TO INCREASE CONSUMER COMPREHENSION AND COMPLIANCE. THE REVISIONS DO NO RESULT IN CHANGES IN THE DEVICES THEMSELVES OR THE INDICATIONS FOR USE OF THE DEVICES |
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