FDA.reportPublic FDA data

PMA P170035S011

Device
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses
Applicant
Bausch and Lomb, Inc.,
PMA number
P170035
Supplement
S011
Product code
LPM
Decision date
2020-11-19
Generic name
Lenses, soft contact, extended wear
Approval order statement
Alternate supplier of a raw material used in the manufacture of the Bausch + Lomb Ultra® (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses.

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
S011
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2020-11-19
Decision code
OK30
Date received
2020-10-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate supplier of a raw material used in the manufacture of the Bausch + Lomb Ultra® (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses.