PMA P100016S008

Device
CT LUCIA Intraocular lens (Model 611P)
Applicant
Carl Zeiss Meditec Production, LLC
PMA number
P100016
Supplement
S008
Product code
HQL
Decision date
2021-07-08
Generic name
intraocular lens
Approval order statement
Approval for a new product model, CT LUCIA 611P, which is a design change to product CT LUCIA 602.

Current openFDA PMA Record#

Device
CT LUCIA Intraocular lens (Model 611P)
Applicant
Carl Zeiss Meditec Production, LLC
PMA number
P100016
Supplement
S008
Product code
HQL
Generic name
intraocular lens
Decision date
2021-07-08
Decision code
APPR
Date received
2020-09-08
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a new product model, CT LUCIA 611P, which is a design change to product CT LUCIA 602.