- Device
- Sensar 1-Piece IOL, Tecnis 1-Piece IOL, Tecnis 1-Piece OptiBlue IOL, Preloaded Tecnis 1-Piece IOL, Preloaded Tecnis 1-Pi
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S082
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2017-06-05
- Decision code
- OK30
- Date received
- 2017-05-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in sampling plan for a quality release test for one-piece, soft acrylic intraocular lenses (IOLs).