FDA.reportPublic FDA data

PMA N16895S103

Device
SofLens (polymacon) Contact Lenses
Applicant
Bausch & Lomb, Inc.
PMA number
N16895
Supplement
S103
Product code
LPM
Decision date
2020-04-13
Generic name
Lenses, soft contact, extended wear
Approval order statement
Change from the use of animal to vegetable-based additives in the production of resin used to make casting molds for production of Soflens® (polymacon) and Soflens® Toric (alphafilcon A) contact lenses at the Rochester, NY and Waterford, Ireland manufacturing sites.

Current openFDA PMA Record#

Device
SofLens (polymacon) Contact Lenses
Applicant
Bausch & Lomb, Inc.
PMA number
N16895
Supplement
S103
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2020-04-13
Decision code
OK30
Date received
2020-03-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change from the use of animal to vegetable-based additives in the production of resin used to make casting molds for production of Soflens® (polymacon) and Soflens® Toric (alphafilcon A) contact lenses at the Rochester, NY and Waterford, Ireland manufacturing sites.