- Device
- SENSAR 3-Piece Monofocal IOL, SENSAR 1-piece IOL, TECNIS Multi-focal 1-pc, TECNIS 1-PC OptiBlue IOL, TECNIS OptiBlue 1-P
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S186
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2026-10-19
- Decision code
- OK30
- Date received
- 2026-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the transfer of microbiology testing from an external contractor to an in-house laboratory to support product manufacturing at the AMO Puerto Rico manufacturing site