PMA P170035S021
- Device
- Bausch + Lomb Ultra (samfilcon A) Contact Lenses
- Applicant
- Bausch and Lomb, Inc.,
- PMA number
- P170035
- Supplement
- S021
- Product code
- LPM
- Decision date
- 2026-09-14
- Classification
- Ophthalmic
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- expansion and relocation of the monomer mix manufacturing area at Bausch + Lomb’s manufacturing facility located in Rochester, NY
Current openFDA PMA Record#
- Device
- Bausch + Lomb Ultra (samfilcon A) Contact Lenses
- Applicant
- Bausch and Lomb, Inc.,
- PMA number
- P170035
- Supplement
- S021
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2026-09-14
- Decision code
- OK30
- Date received
- 2026-08-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- expansion and relocation of the monomer mix manufacturing area at Bausch + Lomb’s manufacturing facility located in Rochester, NY