PMA P170035S018

Device: ULTRA (samfilcon A) Visibility Tinted Soft Contact Lenses
Applicant: Bausch and Lomb, Inc.,
PMA number: P170035
Supplement: S018
Product code: LPM
Decision date: 2025-09-15
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: implement concentration control tanks in manufacturing lines to reduce the IPA usage concentration at Bausch + Lomb’s manufacturing facility located in Rochester, NY

Current openFDA PMA Record#

Device: ULTRA (samfilcon A) Visibility Tinted Soft Contact Lenses
Applicant: Bausch and Lomb, Inc.,
PMA number: P170035
Supplement: S018
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-09-15
Decision code: OK30
Date received: 2025-08-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implement concentration control tanks in manufacturing lines to reduce the IPA usage concentration at Bausch + Lomb’s manufacturing facility located in Rochester, NY