Lenses, Soft Contact, Extended Wear
Basic Information
- Device Name
- Lenses, Soft Contact, Extended Wear
- Trade Name
- FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES
- PMA Number
- P820021
- Supplement Number
- S029
- Device Class
- FDA Class 3
- Product Code
- LPM
- Generic Name
- Lenses, soft contact, extended wear
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 25, 1996
- Date Received
- May 10, 1996
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPM | Lenses, Soft Contact, Extended Wear | FDA class 3 | Ophthalmic |