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PMA P010019S047

Device
FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S047
Product code
LPM
Decision date
2016-03-23
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Manufacturing changes to include the installation and qualification of new (i.e., replacement) systems for the production of phosphate buffered saline and for the production of phosphate buffered saline with hydrogen peroxide at the Batam, Indonesia production facility.

Current openFDA PMA Record#

Device
FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S047
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2016-03-23
Decision code
OK30
Date received
2016-02-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing changes to include the installation and qualification of new (i.e., replacement) systems for the production of phosphate buffered saline and for the production of phosphate buffered saline with hydrogen peroxide at the Batam, Indonesia production facility.