ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER
FDA premarket approval N18033/S037 · decided 2002-03-18
Approval details
- PMA number
- N18033
- Supplement
- S037
- Supplement type
- Special (Immediate Track)
- Trade name
- ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2002-02-19
- Decision date
- 2002-03-18
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- 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 VISU
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