VISTAKON® (etafilcon A) Brand Contact Lenses
FDA premarket approval N18033/S114 · decided 2026-04-17
Approval details
- PMA number
- N18033
- Supplement
- S114
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON® (etafilcon A) Brand Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2026-03-30
- Decision date
- 2026-04-17
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- addition of an alternate raw supplier for subcomponent, Reactive Blue No. 4 (RB4), used in the production of Vistakon (senofilcon A) and Vistakon (etafilcon A) Brand Contact Lenses at the Jacksonville, Florida and Limerick, Ireland manufacturing facilities
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