PMA P980040S078
- Device
- Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S078
- Product code
- HQL
- Decision date
- 2017-03-23
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Add the AMO Kulim, Malaysia manufacturing site for your Tecnis Multifocal IOL Models ZKB00, ZLB00, and ZMB00.
Current openFDA PMA Record#
- Device
- Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S078
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2017-03-23
- Decision code
- OK30
- Date received
- 2017-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add the AMO Kulim, Malaysia manufacturing site for your Tecnis Multifocal IOL Models ZKB00, ZLB00, and ZMB00.