PMA P960022S011

Device: SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS
Applicant: Bausch & Lomb, Inc.
PMA number: P960022
Supplement: S011
Product code: LPM
Decision date: 2015-10-19
Generic name: Lenses, soft contact, extended wear
Approval order statement: QUALIFYING AN ALTERNATE SUPPLIER OF A CRITICAL RAW MATERIAL COMPONENT FOR THE BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) CONTACT LENS.

Current openFDA PMA Record#

Device: SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS
Applicant: Bausch & Lomb, Inc.
PMA number: P960022
Supplement: S011
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2015-10-19
Decision code: OK30
Date received: 2015-09-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: QUALIFYING AN ALTERNATE SUPPLIER OF A CRITICAL RAW MATERIAL COMPONENT FOR THE BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) CONTACT LENS.