PMA P910056S064
- Device
- enVista® Hydrophobic Acrylic Intraocular Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S064
- Product code
- HQL
- Decision date
- 2026-09-30
- Classification
- Ophthalmic
- Generic name
- intraocular lens
- Approval order statement
- adding a new ISO Class 7 manufacturing cleanroom at the Clearwater Florida facility
Current openFDA PMA Record#
- Device
- enVista® Hydrophobic Acrylic Intraocular Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S064
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2026-09-30
- Decision code
- OK30
- Date received
- 2026-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding a new ISO Class 7 manufacturing cleanroom at the Clearwater Florida facility