Carl Zeiss Meditec Inc
Dublin, CA, US
CARL ZEISS MEDITEC INC appears in FDA device records in Dublin, CA. FDA records list 78 510(k) clearances between and , 95 PMA records and 4 registered establishments. As of , FDA records show 29 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Carl Zeiss Meditec Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- CARL ZEISS MEDITEC AG (JENA)registration
- CARL ZEISS MEDITEC AG (OBERKOCHEN)registration
- Carl Zeiss Ophthalmic Systems, Inc.510(k), recall
510(k) clearance history
Showing 50 of 78FDA records hold 78 510(k) clearances for Carl Zeiss Meditec Inc between 1993 and 2026. The busiest year on record is 2023, with 8. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 2 |
| 2009 | 4 |
| 2010 | 4 |
| 2011 | 1 |
| 2012 | 4 |
| 2013 | 4 |
| 2014 | 5 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 6 |
| 2018 | 6 |
| 2019 | 5 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 8 |
| 2024 | 4 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260694 | ZEISS CLINIC 360 | NFJ | Substantially Equivalent | |
| K243878 | CLARUS (700) | QER | Substantially Equivalent | |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | JAD | Substantially Equivalent | |
| K233911 | VISULAS combi | HQF | Substantially Equivalent | |
| K240215 | BLUE 400; BLUE 400 S | QFX | Substantially Equivalent | |
| K233933 | CIRRUS™ HD-OCT Model 6000 | OBO | Substantially Equivalent | |
| K233421 | RESCAN 700 | OBO | Substantially Equivalent | |
| K232944 | CALLISTO eye | NFJ | Substantially Equivalent | |
| K232051 | VISULAS green | HQF | Substantially Equivalent | |
| K230350 | VISULAS yag | HQF | Substantially Equivalent | |
| K232159 | QEVO System | GWG | Substantially Equivalent | |
| K231676 | CALLISTO eye | NFJ | Substantially Equivalent | |
| K230858 | QUATERA 700 | HQC | Substantially Equivalent | |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | IZI | Substantially Equivalent | |
| K222200 | CIRRUS HD-OCT | OBO | Substantially Equivalent | |
| K213527 | FORUM | NFJ | Substantially Equivalent | |
| K211346 | BLUE 400 | QFX | Substantially Equivalent | |
| K212241 | QUATERA 700 | HQC | Substantially Equivalent | |
| K211156 | CONVIVO In Vivo Pathology Suite | LLZ | Substantially Equivalent | |
| K193376 | Visalis V500, Visalis S500 | HQC | Substantially Equivalent | |
| K191194 | CLARUS | QER | Substantially Equivalent | |
| K181682 | VISULAS green | HQF | Substantially Equivalent | |
| K181534 | CIRRUS HD-OCT | OBO | Substantially Equivalent | |
| K180229 | RESCAN 700, CALLISTO eye | OBO | Substantially Equivalent | |
| K181444 | CLARUS | QER | Substantially Equivalent | |
| K181116 | CONVIVO | GWG | Substantially Equivalent | |
| K182318 | Retina Workplace | NFJ | Substantially Equivalent | |
| K173771 | IOLMaster 700 | HJO | Substantially Equivalent | |
| K180858 | CALLISTO eye | NFJ | Substantially Equivalent | |
| K180839 | AT 030 | HKY | Substantially Equivalent | |
| K173371 | VisuMax Femtosecond Laser | HNO | Substantially Equivalent | |
| K170667 | QEVO System with KINEVO 900 | GWG | Substantially Equivalent | |
| K162991 | YELLOW 560 Fluorescence Module | IZI | Unknown | |
| K170638 | Retina Workplace | NFJ | Substantially Equivalent | |
| K162684 | SL 220 | HJO | Substantially Equivalent | |
| K170171 | IOLMaster 700 | HJO | Substantially Equivalent | |
| K161607 | VISULUX | HJO | Substantially Equivalent | |
| K162568 | INTRABEAM 600 | JAD | Substantially Equivalent | |
| K161194 | PLEX Elite 9000 SS-OCT | OBO | Substantially Equivalent | |
| K150977 | CIRRUS HD-OCT | OBO | Substantially Equivalent | |
| K143275 | IOLMaster700 | HJO | Substantially Equivalent | |
| K150467 | Retina Workplace | NFJ | Substantially Equivalent | |
| K141844 | RESCAN 700, CALLISTO EYE | OBO | Substantially Equivalent | |
| K141297 | FORUM GLAUCOMA WORKPLACE | NFJ | Substantially Equivalent | |
| K141068 | ZEISS CATARACT SUITE MARKERLESS | HJO | Substantially Equivalent | |
| K133217 | CIRRUS PHOTO | OBO | Substantially Equivalent | |
| K133476 | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION | HJO | Substantially Equivalent | |
| K130648 | FORUM GLAUCOMA WORKPLACE | NFJ | Substantially Equivalent | |
| K130549 | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR | JAD | Substantially Equivalent | |
| K122418 | IOLMASTER 500 | HJO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3038356864 | 3038356864 | CARL ZEISS MEDITEC AG (JENA) | Goeschwitzer Strasse 51-52, JENA Thuringia 07745 DE | 2026 | and 14 more, listed in full below |
| 9615010 | 3003481798 | CARL ZEISS MEDITEC AG (OBERKOCHEN) | RUDOLF-EBER-STRASSE 11, OBERKOCHEN Baden-Wurttemberg D-73447 DE | 2026 | and 16 more, listed in full below |
| 2918630 | 2918630 | CARL ZEISS MEDITEC INC | 5300 Central Parkway, DUBLIN, CA 94568 US | 2026 | and 4 more, listed in full below |
| 9615030 | 3001362763 | Carl Zeiss Meditec AG (Jena) | Carl-Zeiss-Promenade 10, Jena Thuringia 07745 DE | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- HKICamera, Ophthalmic, Ac-Powered
- QERCamera, Ophthalmic, Slit-Scanning
- KQMCamera, Surgical And Accessories
- KMNChair And Table, Medical
- HOXChart, Visual Acuity
- PTZColposcope (And Colpomicroscope), Exempt
- OWNConfocal Optical Imaging
- NFGDevice, Communications, Images, Ophthalmic
- NFFDevice, Storage, Images, Ophthalmic
- QFXDiagnostic Neurosurgical Microscope Filter
- HMWDrape, Microscope, Ophthalmic
- PUIDrape, Surgical, Exempt
- GWGEndoscope, Neurological
- LZSExcimer Laser System
- OTLFemtosecond Laser System For Refractive Correction
- HNQHook, Ophthalmic
- HLMInstrument, Measuring, Lens, Ac-Powered
- LHOInstrument, Quality-Assurance, Radiologic
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HQLIntraocular Lens
- HNOKeratome, Ac-Powered
- HQFLaser, Ophthalmic
- KYTLight, Examination, Medical, Battery Powered
- HMRMarker, Ocular
- OUGMedical Device Data System
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic
- EPTMicroscope, Surgical
- FSOMicroscope, Surgical, General & Plastic Surgery
- HLIOphthalmoscope, Ac-Powered
- HLJOphthalmoscope, Battery-Powered
- MYCOphthalmoscope, Laser, Scanning
- HOOPerimeter, Ac-Powered
- HPTPerimeter, Automatic, Ac-Powered
- HJAPhotokeratoscope
- GEXPowered Laser Surgical Instrument
- HKORefractometer, Ophthalmic
- HKNRefractor, Manual, Non-Powered, Including Phoropter
- HOHSpectacle, Operating (Loupe), Ophthalmic
- LMDSystem, Digital Image Communications, Radiological
- NFJSystem, Image Management, Ophthalmic
- LLZSystem, Image Processing, Radiological
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- MVFSystem, Laser, Photodynamic Therapy
- JADSystem, Therapeutic, X-Ray
- IZISystem, X-Ray, Angiographic
- HRJTable, Instrument, Powered, Ophthalmic
- OBOTomography, Optical Coherence
- HKXTonometer, Ac-Powered
- HKYTonometer, Manual
- MMQTopographer, Corneal, Ac-Powered
- ITXTransducer, Ultrasonic, Diagnostic
- HJMTransilluminator, Ac-Powered
- HQCUnit, Phacofragmentation
Recall records
Showing 25 of 29| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2649-2026 | Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. | Class II | Open, Classified | |
| Z-1007-2022 | ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery. | High friction of the slider can cause the device to stick, or not move as intended. | Class II | Open, Classified | |
| Z-0723-2022 | CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex | Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance. | Class II | Open, Classified | |
| Z-2227-2021 | Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000" | Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device. | Class II | Open, Classified | |
| Z-1133-2021 | IOLMaster 700 | When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen | Class II | Terminated | |
| Z-0614-2021 | Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses. | Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user. | Class II | Terminated | |
| Z-0613-2021 | Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism. | Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user. | Class II | Terminated | |
| Z-0680-2020 | VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE. | VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to choose the option immediate restart or restart treatment. Suction loss can occur in phase 1 through phase 5. The software defect refers to Phase 2 (between 10% and 100% of lower lenticule cut) only. The software offers a flap cut, but due to the software issue it performs a cap cut instead of a flap cut if the user proceeds. | Class II | Terminated | |
| Z-0770-2020 | The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. | Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch. | Class II | Terminated | |
| Z-0108-2019 | Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01 | Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye. | Class II | Terminated | |
| Z-0001-2018 | Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments | The device had an incorrect printed calibration value on the calibration certificate. | Class II | Terminated | |
| Z-0358-2016 | IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. | Class II | Terminated | |
| Z-0357-2016 | IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation. | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. | Class II | Terminated | |
| Z-1049-2015 | FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management system. | Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data. | Class II | Terminated | |
| Z-1153-2014 | Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting. | Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. | Class II | Terminated | |
| Z-0334-2014 | Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation | The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value. | Class II | Terminated | |
| Z-0333-2014 | Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation | The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value. | Class II | Terminated | |
| Z-1440-2013 | Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field. | Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount. | Class II | Terminated | |
| Z-0406-2013 | INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. | Class II | Terminated | |
| Z-0405-2013 | INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. | Class II | Terminated | |
| Z-0404-2013 | INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. | Class II | Terminated | |
| Z-0105-2012 | OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field. | An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations. | Terminated | ||
| Z-3275-2011 | OPMI Pentero, OPMI Pentero C, OPMI Pentero 900, OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro Multivision/NC4, OPMI Vario/NC33, OPMI Neuro/NC4, OPMI Neuro/NC4 Ceiling Mount. A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area. | Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems. | Terminated | ||
| Z-2989-2011 | INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments. | Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol, | Terminated | ||
| Z-2127-2011 | Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0 The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. | A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain