Lenses, Soft Contact, Extended Wear
Basic Information
- Device Name
- Lenses, Soft Contact, Extended Wear
- Trade Name
- ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER
- PMA Number
- N18033
- Supplement Number
- S037
- 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
- March 18, 2002
- Date Received
- February 19, 2002
- Supplement Type
- Special (Immediate Track)
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR LABELING CHANGES FOR THE DEVICE. THE CHANGES WILL ADD ADDITIONAL STATEMENTS TO THE "PRECAUTIONS" SECTION OF THE PACKAGE INSERT TO ALERT BOTH DOCTORS AND PATIENTS ABOUT VISUAL SYMPTOMS AND/OR PERIPHERAL AWARENESS THAT PATIENTS MIGHT EXPERIENCE DUE TO A REDUCTION IN THE VISIBLE LIGHT TRANSMISSION. THE FOLLOWING ADDITIONAL PRECAUTION STATEMENT WILL BE ADDED TO THE PACKAGE INSERT: "DUE TO REDUCTION IN LIGHT TRANSMITTANCE WITH COSMETICALLY TINTED LENSES, SOME PATIENTS MAY EXPERIENCE VISUAL SYMPTOMS WHILE WEARING ACUVUE 2 COLOURS BRAND. IN ADDITION, SOME PATIENTS MAY EXPERIENCE PERIPHERAL AWARENESS DUE TO THE OPAQUE IRIS PATTERN." THE FOLLOWING ADDITIONAL PRECAUTION STATEMENT WILL BE ADDED TO THE PATIENT INSTRUCTION GUIDES: "WHEN WEARING LENSES THAT ALTER YOUR EYE COLOR, YOU MAY NOTICE TEMPORARY DIFFERENCES IN YOUR VISION DUE TO A CHANGE IN THE AMOUNT OF LIGHT THAT ENTERS YOUR EYES. IF THESE DIFFERENCES IN VISION PERSIST WHEN WEARING ACUVUE 2 COLOURS BRAND, IT IS IMPORTANT THAT YOU CONSULT YOUR EYE CARE PROFESSIONAL."
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 |