PMA P980040S132
- Device
- TECNIS Symfony™ OptiBlue™ Extended Range of Vision (ERV) IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S132
- Product code
- HQL
- Decision date
- 2021-03-23
- Generic name
- intraocular lens
- Approval order statement
- Change to the manufacturing process of the TECNIS Symfony Optiblue ERV IOL, Model ZXR00V, at the Puerto Rico facility.
Current openFDA PMA Record#
- Device
- TECNIS Symfony™ OptiBlue™ Extended Range of Vision (ERV) IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S132
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-03-23
- Decision code
- OK30
- Date received
- 2021-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the manufacturing process of the TECNIS Symfony Optiblue ERV IOL, Model ZXR00V, at the Puerto Rico facility.