PMA P100016S004

Device: CT LUCIA 202 IOL and CT LUCIA 602 IOL
Applicant: Carl Zeiss Meditec Production, LLC
PMA number: P100016
Supplement: S004
Product code: HQL
Decision date: 2017-08-09
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Approval for change in product name from Aaris® EC-3 and Aaris® EC-3 PAL to CT LUCIA 202 and CT LUCIA 602 respectively; minor product labeling changes to include the unit container box, adhesive label, Instructions for Use and patient card; and a new contact/manufacturing address.

Current openFDA PMA Record#

Device: CT LUCIA 202 IOL and CT LUCIA 602 IOL
Applicant: Carl Zeiss Meditec Production, LLC
PMA number: P100016
Supplement: S004
Product code: HQL
Generic name: intraocular lens
Decision date: 2017-08-09
Decision code: APPR
Date received: 2017-05-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for change in product name from Aaris® EC-3 and Aaris® EC-3 PAL to CT LUCIA 202 and CT LUCIA 602 respectively; minor product labeling changes to include the unit container box, adhesive label, Instructions for Use and patient card; and a new contact/manufacturing address.