PMA P910056S048
- Device
- enVista® hydrophobic acrylic intraocular lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S048
- Product code
- HQL
- Decision date
- 2021-10-14
- Generic name
- intraocular lens
- Approval order statement
- Change to the metrology equipment used for dioptric power and image quality measurements of enVista® Hydrophobic Acrylic Intraocular Lenses.
Current openFDA PMA Record#
- Device
- enVista® hydrophobic acrylic intraocular lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S048
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-10-14
- Decision code
- OK30
- Date received
- 2021-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the metrology equipment used for dioptric power and image quality measurements of enVista® Hydrophobic Acrylic Intraocular Lenses.