PMA P860022
- Device
- Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A)
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S059
- Product code
- MWL
- Decision date
- 2025-12-16
- Classification
- Lens, Contact (rigid Gas Permeable), Extended Wear
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Approval order statement
- installation and validation of two Large Diameter (Scleral) Lathes at the Bausch + Lomb facility located in Wilmington, MA
Current openFDA PMA Record#
- Device
- Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A)
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S061
- Product code
- MWL
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Decision date
- 2025-12-16
- Decision code
- OK30
- Date received
- 2025-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- installation and validation of two Large Diameter (Scleral) Lathes at the Bausch + Lomb facility located in Wilmington, MA