- Device
- TECNIS Family of 1-piece IOLs packaged in the Daisy Wheel Configuration
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S141
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-07-28
- Decision code
- OK30
- Date received
- 2021-07-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Slight increase to the lower tolerance for the ring height for the lens insert of the daisy-wheel package configuration for one-piece acrylic IOLs.