Zeiss 3-piece Hydrophobic Acrylic Intraocular lens (IOL)

FDA Premarket Approval P100016 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for changes in manufacturing with installation of new equipment and process accessories for machining, tumbling, assembly, and inspection for 3-piece intraocular lens models ct lucia 202 and ct lucia 602.

DeviceZeiss 3-piece Hydrophobic Acrylic Intraocular lens (IOL)
Generic NameIntraocular Lens
ApplicantCarl Zeiss Meditec Production LLC
Date Received2020-08-31
Decision Date2021-05-13
PMAP100016
SupplementS007
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Carl Zeiss Meditec Production LLC 1040 South Vintage Avenue, Bldg. A ontario, CA 91761-3631

Supplemental Filings

Supplement NumberDateSupplement Type
P100016Original Filing
S007 2020-08-31 135 Review Track For 30-day Notice
S006 2018-08-24 30-day Notice
S005 2018-02-08 30-day Notice
S004 2017-05-22 Normal 180 Day Track No User Fee
S003 2017-03-24 Special (immediate Track)
S002 2014-12-18 Normal 180 Day Track No User Fee
S001 2013-02-19 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00843045100614 P100016 004
00843045100775 P100016 004
00843045100782 P100016 004
00843045100799 P100016 004
00843045100805 P100016 004
00843045100812 P100016 004
00843045100829 P100016 004
00843045100836 P100016 004
00843045100843 P100016 004
00843045100850 P100016 004
00843045100867 P100016 004
00843045100874 P100016 004
00843045100881 P100016 004
00843045100898 P100016 004
00843045100768 P100016 004
00843045100751 P100016 004
00843045100621 P100016 004
00843045100638 P100016 004
00843045100645 P100016 004
00843045100652 P100016 004
00843045100669 P100016 004
00843045100676 P100016 004
00843045100683 P100016 004
00843045100690 P100016 004
00843045100706 P100016 004
00843045100713 P100016 004
00843045100720 P100016 004
00843045100737 P100016 004
00843045100744 P100016 004
00843045100904 P100016 004
00843045100911 P100016 004
00843045100928 P100016 004
00843045101086 P100016 004
00843045101093 P100016 004
00843045101109 P100016 004
00843045101116 P100016 004
00843045101123 P100016 004
00843045101130 P100016 004
00843045101147 P100016 004
00843045101154 P100016 004
00843045101161 P100016 004
00843045101178 P100016 004
00843045101185 P100016 004
00843045101192 P100016 004
00843045101208 P100016 004
00843045101079 P100016 004
00843045101062 P100016 004
00843045100935 P100016 004
00843045100942 P100016 004
00843045100959 P100016 004
00843045100966 P100016 004
00843045100973 P100016 004
00843045100980 P100016 004
00843045100997 P100016 004
00843045101000 P100016 004
00843045101017 P100016 004
00843045101024 P100016 004
00843045101031 P100016 004
00843045101048 P100016 004
00843045101055 P100016 004
00843045101215 P100016 004

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.