CT LUCIA 003500-0056-648

GUDID 00843045103448

1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +13.0D

CARL ZEISS MEDITEC PRODUCTION, LLC

Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic
Primary Device ID00843045103448
NIH Device Record Key6fc2fcd8-9394-407a-9353-c376cb48179c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT LUCIA
Version Model NumberCT LUCIA 611P.AM DPT 13.0
Catalog Number003500-0056-648
Company DUNS080685425
Company NameCARL ZEISS MEDITEC PRODUCTION, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100843045103448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQLIntraocular Lens

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-27
Device Publish Date2021-07-19

On-Brand Devices [CT LUCIA]

008430451012153-piece, monofocal, hydrophobic, acrylic, intraocular lens, +34.0D
008430451012083-piece, monofocal, hydrophobic, acrylic, intraocular lens, +33.5D
008430451011923-piece, monofocal, hydrophobic, acrylic, intraocular lens, +33.0D
008430451011853-piece, monofocal, hydrophobic, acrylic, intraocular lens, +32.5D
008430451011783-piece, monofocal, hydrophobic, acrylic, intraocular lens, +32.0D
008430451011613-piece, monofocal, hydrophobic, acrylic, intraocular lens, +31.5D
008430451011543-piece, monofocal, hydrophobic, acrylic, intraocular lens, +31.0D
008430451011473-piece, monofocal, hydrophobic, acrylic, intraocular lens, +30.5D
008430451011303-piece, monofocal, hydrophobic, acrylic, intraocular lens, +30.0D
008430451011233-piece, monofocal, hydrophobic, acrylic, intraocular lens, +29.5D
008430451011163-piece, monofocal, hydrophobic, acrylic, intraocular lens, +29.0D
008430451011093-piece, monofocal, hydrophobic, acrylic, intraocular lens, +28.5D
008430451010933-piece, monofocal, hydrophobic, acrylic, intraocular lens, +28.0D
008430451010863-piece, monofocal, hydrophobic, acrylic, intraocular lens, +27.5D
008430451010793-piece, monofocal, hydrophobic, acrylic, intraocular lens, +27.0D
008430451010623-piece, monofocal, hydrophobic, acrylic, intraocular lens, +26.5D
008430451010553-piece, monofocal, hydrophobic, acrylic, intraocular lens, +26.0D
008430451010483-piece, monofocal, hydrophobic, acrylic, intraocular lens, +25.5D
008430451010313-piece, monofocal, hydrophobic, acrylic, intraocular lens, +25.0D
008430451010243-piece, monofocal, hydrophobic, acrylic, intraocular lens, +24.5D
008430451010173-piece, monofocal, hydrophobic, acrylic, intraocular lens, +24.0D
008430451010003-piece, monofocal, hydrophobic, acrylic, intraocular lens, +23.5D
008430451009973-piece, monofocal, hydrophobic, acrylic, intraocular lens, +23.0D
008430451009803-piece, monofocal, hydrophobic, acrylic, intraocular lens, +22.5D
008430451009733-piece, monofocal, hydrophobic, acrylic, intraocular lens, +22.0D
008430451009663-piece, monofocal, hydrophobic, acrylic, intraocular lens, +21.5D
008430451009593-piece, monofocal, hydrophobic, acrylic, intraocular lens, +21.0D
008430451009423-piece, monofocal, hydrophobic, acrylic, intraocular lens, +20.5D
008430451009353-piece, monofocal, hydrophobic, acrylic, intraocular lens, +20.0D
008430451009283-piece, monofocal, hydrophobic, acrylic, intraocular lens, +19.5D
008430451009113-piece, monofocal, hydrophobic, acrylic, intraocular lens, +19.0D
008430451009043-piece, monofocal, hydrophobic, acrylic, intraocular lens, +18.5D
008430451008983-piece, monofocal, hydrophobic, acrylic, intraocular lens, +18.0D
008430451008813-piece, monofocal, hydrophobic, acrylic, intraocular lens, +17.5D
008430451008743-piece, monofocal, hydrophobic, acrylic, intraocular lens, +17.0D
008430451008673-piece, monofocal, hydrophobic, acrylic, intraocular lens, +16.5D
008430451008503-piece, monofocal, hydrophobic, acrylic, intraocular lens, +16.0D
008430451008433-piece, monofocal, hydrophobic, acrylic, intraocular lens, +15.5D
008430451008363-piece, monofocal, hydrophobic, acrylic, intraocular lens, +15.0D
008430451008293-piece, monofocal, hydrophobic, acrylic, intraocular lens, +14.5D
008430451008123-piece, monofocal, hydrophobic, acrylic, intraocular lens, +14.0D
008430451008053-piece, monofocal, hydrophobic, acrylic, intraocular lens, +13.5D
008430451007993-piece, monofocal, hydrophobic, acrylic, intraocular lens, +13.0D
008430451007823-piece, monofocal, hydrophobic, acrylic, intraocular lens, +12.5D
008430451007753-piece, monofocal, hydrophobic, acrylic, intraocular lens, +12.0D
008430451007683-piece, monofocal, hydrophobic, acrylic, intraocular lens, +11.5D
008430451007513-piece, monofocal, hydrophobic, acrylic, intraocular lens, +11.0D
008430451007443-piece, monofocal, hydrophobic, acrylic, intraocular lens, +10.5D
008430451007373-piece, monofocal, hydrophobic, acrylic, intraocular lens, +10.0D
008430451007203-piece, monofocal, hydrophobic, acrylic, intraocular lens, +9.5D

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.