PMA P910056S046
- Device
- enVista Hydrophobic Acrylic Intraocular Lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S046
- Product code
- HQL
- Decision date
- 2021-07-21
- Generic name
- intraocular lens
- Approval order statement
- Use of alternative milling equipment, including vacuum plate and protective, to manufacture process for enVista Hydrophobic Acrylic Intraocular Lens.
Current openFDA PMA Record#
- Device
- enVista Hydrophobic Acrylic Intraocular Lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S046
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-07-21
- Decision code
- OK30
- Date received
- 2021-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of alternative milling equipment, including vacuum plate and protective, to manufacture process for enVista Hydrophobic Acrylic Intraocular Lens.