PMA P860022S061

Device: Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A)
Applicant: Bausch & Lomb
PMA number: P860022
Supplement: S061
Product code: MWL
Decision date: 2025-12-16
Classification: Ophthalmic
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