PMA P910056S028
- Device
- EnVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL), Model MX60E Lens Holder
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S028
- Product code
- HQL
- Decision date
- 2017-12-04
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Modification of the lens holder surface finish.
Current openFDA PMA Record#
- Device
- EnVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL), Model MX60E Lens Holder
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S028
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2017-12-04
- Decision code
- OK30
- Date received
- 2017-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of the lens holder surface finish.