PMA P980006S033

Device: Bausch+ Lomb Pure Vision® (balafilcon A) Visibility Tinted Soft Contact Lenses
Applicant: Bausch & Lomb, Inc.
PMA number: P980006
Supplement: S033
Product code: LPM
Decision date: 2022-01-13
Generic name: Lenses, soft contact, extended wear
Approval order statement: Adding an alternate supplier of a raw material for the Ultra (samfilcon A) and Pure Vision (balafilcon A) contact lens products.

Current openFDA PMA Record#

Device: Bausch+ Lomb Pure Vision® (balafilcon A) Visibility Tinted Soft Contact Lenses
Applicant: Bausch & Lomb, Inc.
PMA number: P980006
Supplement: S033
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-01-13
Decision code: OK30
Date received: 2021-12-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Adding an alternate supplier of a raw material for the Ultra (samfilcon A) and Pure Vision (balafilcon A) contact lens products.