- Device
- VISTAKON® (senofilcon A) contact lenses
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- PMA number
- P040045
- Supplement
- S144
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2026-05-04
- Decision code
- OK30
- Date received
- 2026-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of alternate equipment (Solvent Hydration Module Tower Extension and Steam Sterilizer Replacement) on an existing manufacturing line, at the manufacturing facility located in Jacksonville, Florida