- Device
- Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl
- Applicant
- Bausch & Lomb
- PMA number
- P860022
- Supplement
- S060
- Product code
- MWL
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Decision date
- 2024-07-18
- Decision code
- OK30
- Date received
- 2024-06-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- transfer of existing monomer synthesis operations for two monomers from the same supplier to a different manufacturing facility in Riegelwood, NC