PMA P170035

Device: Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses
Applicant: Bausch and Lomb, Inc.,
PMA number: P170035
Supplement: S017
Product code: LPM
Decision date: 2025-12-04
Generic name: Lenses, soft contact, extended wear
Approval order statement: implement a textured blister foil and lower solution film volume at Bausch + Lomb’s manufacturing facility located in Rochester, NY

Current openFDA PMA Record#

Device: Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses
Applicant: Bausch and Lomb, Inc.,
PMA number: P170035
Supplement: S019
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-12-04
Decision code: OK30
Date received: 2025-10-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implement a textured blister foil and lower solution film volume at Bausch + Lomb’s manufacturing facility located in Rochester, NY