PMA P910061S026
- Device
- enVista One-Piece Foldable Acrylic Intraocular Lens (IOL)
- Applicant
- Bausch & Lomb
- PMA number
- P910061
- Supplement
- S026
- Product code
- HQL
- Decision date
- 2021-01-04
- Generic name
- intraocular lens
- Approval order statement
- New process for electroplating molds for intraocular lens models LI61SE and LI61AO.
Current openFDA PMA Record#
- Device
- enVista One-Piece Foldable Acrylic Intraocular Lens (IOL)
- Applicant
- Bausch & Lomb
- PMA number
- P910061
- Supplement
- S026
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-01-04
- Decision code
- OK30
- Date received
- 2020-12-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New process for electroplating molds for intraocular lens models LI61SE and LI61AO.