PMA P100016S006

Device
CT LUCIA 202 and CT LUCIA 602 intraocular lenses
Applicant
Carl Zeiss Meditec Production, LLC
PMA number
P100016
Supplement
S006
Product code
HQL
Decision date
2018-09-20
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Add an alternative machine for lens haptic hole drilling for the CT LUCIA 202 and CT LUCIA 602 intraocular lenses.

Current openFDA PMA Record#

Device
CT LUCIA 202 and CT LUCIA 602 intraocular lenses
Applicant
Carl Zeiss Meditec Production, LLC
PMA number
P100016
Supplement
S006
Product code
HQL
Generic name
intraocular lens
Decision date
2018-09-20
Decision code
OK30
Date received
2018-08-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add an alternative machine for lens haptic hole drilling for the CT LUCIA 202 and CT LUCIA 602 intraocular lenses.