PMA P000030S003

Device: FOCUS NIGHT & DAY (LOTRAFILCON A) EXTENDED WEAR SOFT CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P000030
Supplement: S003
Product code: LPM
Decision date: 2016-06-23
Generic name: Lenses, soft contact, extended wear
Approval order statement: Qualification of two FTNIR instruments that are used for Betacon Macromer raw material incoming inspection quality control testing.

Current openFDA PMA Record#

Device: FOCUS NIGHT & DAY (LOTRAFILCON A) EXTENDED WEAR SOFT CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P000030
Supplement: S003
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2016-06-23
Decision code: OK30
Date received: 2016-06-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of two FTNIR instruments that are used for Betacon Macromer raw material incoming inspection quality control testing.