- Device
- TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL, TECNIS Multifocal 1-Piece IOLs, TECNIS Toric 1-Piece IOLs, TECNIS Toric
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S090
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2018-06-12
- Decision code
- OK30
- Date received
- 2018-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Second purified water generation system at Johnson & Johnson Surgical Inc.'s AMO Groningen manufacturing facility.