- Device
- TECNIS Foldable Acrylic IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P990080
- Supplement
- S054
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-11-12
- Decision code
- OK30
- Date received
- 2020-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an alternative supplier for the thermal initiator used at the Johnson and Johnson Surgical Vision, Inc. (JJSV) Añasco facility in Puerto Rico for IOL production