FDA.reportPublic FDA data

CT LUCIA

Primary DI
00843045101079
Brand
CT LUCIA
Company
CARL ZEISS MEDITEC PRODUCTION, LLC
Model
CT LUCIA 602.US/+27.0D
Catalog number
003500-0050-686
Device description
3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +27.0D
Published
2017-10-01
Public version status
Update
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
P100016004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100016004EC-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
00843045101079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843045101079008430451010798430451010790843045101079

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.

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
00843045101888CT LUCIACT LUCIA 621P.AM DPT 00.0003500-0056-4222023-02-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05414846625238FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625245FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625252FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625269FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625276FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625283FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625290FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
05414846625306FINEVISION HP Trifocal IOLPhysiolHQL2026-06-04
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
10757770606594enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606600enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606617enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606624enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606631enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606648enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606655enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606662enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606679enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606686enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606693enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606709enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05
10757770606716enVista Aspire™ Toric IOLBausch & Lomb IncorporatedHQL2026-04-05