O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
FDA premarket approval P010019/S003 · decided 2004-09-27
Approval details
- PMA number
- P010019
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2004-06-08
- Decision date
- 2004-09-27
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR 1) A MODIFICATION TO THE LOTRAFILCON A MATERIAL TO MARKET LOTRAFILCON B CONTACT LENSES WITH AN INDICATION FOR UP TO 6 NIGHTS OF EXTENDED WEAR; 2) INCORPORATION OF A LIGHT BLUE HANDLING TINT, COPPER PHTHALOCYANINE, TO BOTH THE LOTRAFILCON A AND LOTRAFILCON B LENS MATERIALS; AND 3) A LABELING CHANGE FOR LOTRAFILCON A LENSES TO ALLOW FOR USE WITH ENZYMATIC CLEANERS. THE LOTRAFILCON B LENS WILL BE MARKETED UNDER THE TRADE NAME O2 OPTIX (LOTRAFILCON B) SOFT CONTACT LENSES FOR EXTENDED WE
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