- Device
- One-Piece IOLs with Daisy-Wheel packaging configuration, TENIC iTEC Preloaded Delivery System, TECNIS SmartLOAD Delivery
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S119
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-08-03
- Decision code
- OK30
- Date received
- 2020-07-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Align the flat time test procedure using mainly one (1) representative procedure (QI356) to perform flat time test as opposed to using various procedures for different packaging configurations/delivery systems.