PMA P100016S026

Device
CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P
Applicant
Carl Zeiss Meditec Production, LLC
PMA number
P100016
Supplement
S026
Product code
HQL
Decision date
2026-08-06
Classification
Ophthalmic
Generic name
intraocular lens
Approval order statement
changes to the in-process haptic thickness measurements of the CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P intraocular lenses

Current openFDA PMA Record#

Device
CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P
Applicant
Carl Zeiss Meditec Production, LLC
PMA number
P100016
Supplement
S026
Product code
HQL
Generic name
intraocular lens
Decision date
2026-08-06
Decision code
OK30
Date received
2026-07-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
changes to the in-process haptic thickness measurements of the CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P intraocular lenses