- Device
- SENSAR 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS O
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S130
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-02-22
- Decision code
- OK30
- Date received
- 2021-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualify expansion of manufacturing area to Building 3 of AMO Puerto Rico facility for SmartLoad Delivery Technology and TECNIS Simplicity Delivery System devices that are approved and manufactured in Building 1 of this facility.