PMA P170035S016

Device: Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses
Applicant: Bausch and Lomb, Inc.,
PMA number: P170035
Supplement: S016
Product code: LPM
Decision date: 2022-03-21
Generic name: Lenses, soft contact, extended wear
Approval order statement: Change to the distillation and storage bottle stabilizer used in the manufacture of the Ultra® (samfilcon A) and Pure Vision (balafilcon A)® product families.

Current openFDA PMA Record#

Device: Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses
Applicant: Bausch and Lomb, Inc.,
PMA number: P170035
Supplement: S016
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-03-21
Decision code: OK30
Date received: 2022-02-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the distillation and storage bottle stabilizer used in the manufacture of the Ultra® (samfilcon A) and Pure Vision (balafilcon A)® product families.