PMA P100016S014

Device: CT Lucia 602, CT Lucia 202, CT Lucia 611P
Applicant: Carl Zeiss Meditec Production, LLC
PMA number: P100016
Supplement: S014
Product code: HQL
Decision date: 2022-05-13
Generic name: intraocular lens
Approval order statement: Changing the measurement system used for hydrophobic button diameter measurements in CT Lucia 602, CT Lucia 202, and CT Lucia 611P intraocular lens production.

Current openFDA PMA Record#

Device: CT Lucia 602, CT Lucia 202, CT Lucia 611P
Applicant: Carl Zeiss Meditec Production, LLC
PMA number: P100016
Supplement: S014
Product code: HQL
Generic name: intraocular lens
Decision date: 2022-05-13
Decision code: OK30
Date received: 2022-04-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changing the measurement system used for hydrophobic button diameter measurements in CT Lucia 602, CT Lucia 202, and CT Lucia 611P intraocular lens production.