- Device
- Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1-Piece IOL, iTec Preloaded Delivery System, Multifocal 1-Piece IOL, Mu
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S108
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2019-10-15
- Decision code
- OK30
- Date received
- 2019-09-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Consolidation of the cosmetic inspection step of the one-piece and three-piece intraocular lenses.