PMA P910056S066
- Device
- enVista® Hydrophobic Acrylic Intraocular Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S066
- Product code
- HQL
- Decision date
- 2026-10-14
- Classification
- Ophthalmic
- Generic name
- intraocular lens
- Approval order statement
- increasing the production lot size and extending the unrefrigerated holding time
Current openFDA PMA Record#
- Device
- enVista® Hydrophobic Acrylic Intraocular Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S066
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2026-10-14
- Decision code
- OK30
- Date received
- 2026-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- increasing the production lot size and extending the unrefrigerated holding time