PMA P910056
- Device
- enVista® Hydrophobic Acrylic Intraocular Lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S049
- Product code
- HQL
- Decision date
- 2025-06-18
- Generic name
- intraocular lens
- Approval order statement
- qualification of a new lathe for enVista IOLs manufacturing
Current openFDA PMA Record#
- Device
- enVista® Hydrophobic Acrylic Intraocular Lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S060
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2025-06-18
- Decision code
- OK30
- Date received
- 2025-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of a new lathe for enVista IOLs manufacturing