FDA.reportPublic FDA data

CT LUCIA

Primary DI
00843045101888
Brand
CT LUCIA
Company
CARL ZEISS MEDITEC PRODUCTION, LLC
Model
CT LUCIA 621P.AM DPT 00.0
Catalog number
003500-0056-422
Device description
1-piece, monofocal, hydrophobic, acrylic, intraocular lens, +00.0D
Published
2023-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQLIntraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100016009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100016009EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOLCarl Zeiss Meditec Production, LLC2010-10-19HQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843045101888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843045101888008430451018888430451018880843045101888

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080685425
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843045101895CT LUCIACT LUCIA 621P.AM DPT 00.5003500-0056-4232023-02-24
00843045101901CT LUCIACT LUCIA 621P.AM DPT 01.0003500-0056-4242023-02-24
00843045101918CT LUCIACT LUCIA 621P.AM DPT 01.5003500-0056-4252023-02-24
00843045101925CT LUCIACT LUCIA 621P.AM DPT 02.0003500-0056-4262023-02-24
00843045101932CT LUCIACT LUCIA 621P.AM DPT 02.5003500-0056-4272023-02-24
00843045101949CT LUCIACT LUCIA 621P.AM DPT 03.0003500-0056-4282023-02-24
00843045101956CT LUCIACT LUCIA 621P.AM DPT 03.5003500-0056-4292023-02-24
00843045101963CT LUCIACT LUCIA 621P.AM DPT 04.0003500-0056-4502023-02-24
00843045101970CT LUCIACT LUCIA 621P.AM DPT 04.5003500-0056-4512023-02-24
00843045101987CT LUCIACT LUCIA 621P.AM DPT 05.0003500-0056-4522023-02-24
00843045101994CT LUCIACT LUCIA 621P.AM DPT 05.5003500-0056-4532023-02-24
00843045102007CT LUCIACT LUCIA 621P.AM DPT 06.0003500-0056-4542023-02-24
00843045102014CT LUCIACT LUCIA 621P.AM DPT 06.5003500-0056-4552023-02-24
00843045102021CT LUCIACT LUCIA 621P.AM DPT 07.0003500-0056-4562023-02-24
00843045102038CT LUCIACT LUCIA 621P.AM DPT 07.5003500-0056-4572023-02-24
00843045102045CT LUCIACT LUCIA 621P.AM DPT 08.0003500-0056-4582023-02-24
00843045102052CT LUCIACT LUCIA 621P.AM DPT 08.5003500-0056-4592023-02-24
00843045102069CT LUCIACT LUCIA 621P.AM DPT 09.0003500-0056-4602023-02-24
00843045102076CT LUCIACT LUCIA 621P.AM DPT 09.5003500-0056-4612023-02-24
00843045102083CT LUCIACT LUCIA 621P.AM DPT 10.0003500-0056-4622023-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770606495enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606501enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606518enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606525enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606532enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606549enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606563enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606570enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606587enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
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10757770606624enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606631enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
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10757770606686enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
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10757770606709enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606716enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606723enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606730enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606747enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606754enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606761enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606778enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606785enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606792enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05