VISTAKON® (etafilcon A) lenses
FDA premarket approval N18033/S113 · decided 2026-03-10
Approval details
- PMA number
- N18033
- Supplement
- S113
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON® (etafilcon A) lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2026-02-10
- Decision date
- 2026-03-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- implementation of Cooper Tungsten (CuW) heat seal die plates for the production of Vistakon (etafilcon A) Brand Contact Lenses on Line 30 at the Limerick, Ireland manufacturing facility
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