PMA P010019S080

Device
Lotralcon B soft contact lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S080
Product code
LPM
Decision date
2021-09-28
Generic name
Lenses, soft contact, extended wear
Approval order statement
Implementation of an automated lens loading system at the primary packaging lines for Lotralcon B soft contact lenses for extended wear

Current openFDA PMA Record#

Device
Lotralcon B soft contact lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S080
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2021-09-28
Decision code
OK30
Date received
2021-08-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an automated lens loading system at the primary packaging lines for Lotralcon B soft contact lenses for extended wear