FDA.reportPublic FDA data

PMA P010019S066

Device
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S066
Product code
LPM
Decision date
2018-07-24
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Implementation of a Strip Blister Inspection System at the packaging lines in the production of Lotrafilcon A and Lotrafilcon B Soft Contact Lenses at Alcon's Batam, Indonesia production facility.

Current openFDA PMA Record#

Device
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S066
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2018-07-24
Decision code
OK30
Date received
2018-06-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a Strip Blister Inspection System at the packaging lines in the production of Lotrafilcon A and Lotrafilcon B Soft Contact Lenses at Alcon's Batam, Indonesia production facility.