FDA.reportPublic FDA data

MICOR Auto I/A

Primary DI
00850005541080
Brand
MICOR Auto I/A
Company
Carl Zeiss Meditec, Cataract Technology, Inc.
Model
FG-51820
Device description
MICOR Automatic Irrigation Device
Published
2025-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQCUnit, Phacofragmentation
MLZVitrectomy, Instrument Cutter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2
MLZVitrectomy, Instrument CutterOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243395000MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.2025-08-08HQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005541080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005541080008500055410808500055410800850005541080

GMDN Terms#

Term, Definition table
TermDefinition
Phacoemulsification/vitrectomy systemAn assembly of ophthalmic devices intended to deliver energies (e.g., ultrasonic, piezoelectric, high frequency current) through dedicated handpieces and tips that are introduced through an incision or incisions made in the eye, for the purpose of performing phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It typically consists of a generator providing the energy, irrigation and suction system for the removal of the debris, a tamponade system (e.g., silicone and air), diathermy device, intraocular illuminator, handpieces and cables, the tips/needles/electrodes, and a foot control.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
775-473-1014qualitycti.med.us@zeiss.com

Regulatory Flags#

DUNS number
080125056
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005541073miLOOP reusableFG-508962024-08-30
00860000122306miLOOP1042019-02-12
30850005541074miLOOP reusableFG-508962024-08-30
00850005541042MICOR VitrectorFG-508292023-07-28
00860000122368MICOR extractorFG-506212021-01-29
00860000122375MICOR driveFG-506312021-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770060464Bausch + LombBausch & Lomb IncorporatedHQC2026-04-09
07630055210319Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210326Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210333Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210807Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210814Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210821Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055252883HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055253293Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410762Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410786Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410809Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
08717872035390Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035413TotalView Endoillumination Probe, including illuminated scleral depressor.(27 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035437Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
0871787203553627G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035604Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036595Disposable EVA DrapesD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036601Disposable EVA VGPC Input SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
07630003915709Oertli®Oertli-Instrumente AGHQC2024-10-15
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-09-27
08717872034652EVA Vitrectomy Pack VGPC Input 20GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034683EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034690EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034706EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034744EVA NEXUS™ Combined 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034768EVA NEXUS™ Combined 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034782EVA NEXUS™ Combined 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20