- Device
- JJSV's One-Piece IOL's with Daisy-Whell packaging configuration, JJSV's One-Piece IOLs with TECNIS SmartLOAD Delivery Te
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S151
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2022-10-27
- Decision code
- OK30
- Date received
- 2022-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the location to perform the repackaging activity of Trimethoxysilane Polyethylene Glycol (mPEG) and its receiving testing in Puerto Rico facility.