PMA P010019S083

Device
Lotrafilcon A and B Soft Contact Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S083
Product code
LPM
Decision date
2022-07-06
Generic name
Lenses, soft contact, extended wear
Approval order statement
Adding an alternate supplier for the primary packaging material of Alcon lotrafilcon A and B soft contact lens products.

Current openFDA PMA Record#

Device
Lotrafilcon A and B Soft Contact Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S083
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2022-07-06
Decision code
OK30
Date received
2022-06-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding an alternate supplier for the primary packaging material of Alcon lotrafilcon A and B soft contact lens products.