- Device
- TECNIS OptiBlue 1-Piece IOL, TECNIS OptiBlue Monofocal 1-Piece with Smart LOAD Delivery Technology, TECNIS 1-Piece OptiB
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S128
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-01-08
- Decision code
- OK30
- Date received
- 2020-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of the sampling plan and monomer residual testing for soft acrylic OptiBlue material.