PMA P980040S104
- Device
- Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1-Piece IOL, iTec Preloaded Delivery System, Multifocal 1-Piece IOL, To
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S104
- Product code
- HQL
- Decision date
- 2019-07-18
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Expansion of the manufacturing facility in Puerto Rico.
Current openFDA PMA Record#
- Device
- Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1-Piece IOL, iTec Preloaded Delivery System, Multifocal 1-Piece IOL, To
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S104
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2019-07-18
- Decision code
- OK30
- Date received
- 2019-06-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of the manufacturing facility in Puerto Rico.