- Device
- VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses for ASTIGMATISM with HYDRACLEAR Plus
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- PMA number
- P040045
- Supplement
- S119
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2020-11-23
- Decision code
- OK30
- Date received
- 2020-10-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of an existing production line to produce VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses for ASTIGMATISM with HYDRACLEAR Plus.