PMA P080010S021
- Device
- TECNIS® Multifocal Foldable Posterior Chamber IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P080010
- Supplement
- S021
- Product code
- MFK
- Decision date
- 2022-12-06
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- Adding an alternative supplier for the lens case assembly (LCA).
Current openFDA PMA Record#
- Device
- TECNIS® Multifocal Foldable Posterior Chamber IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P080010
- Supplement
- S021
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2022-12-06
- Decision code
- OK30
- Date received
- 2022-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an alternative supplier for the lens case assembly (LCA).