Data / Medical devices / United States / Carl Zeiss Meditec Inc
Carl Zeiss Meditec Inc: FDA-registered device maker in Dublin, CA, United States, 18 510(k) clearances
Carl Zeiss Meditec Inc is registered with the FDA (registration 2918630) in Dublin, CA, United States. It lists 14 device types. The FDA files 18 510(k) clearances under its listings, the newest dated April 17, 2025. 14 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2918630
- Address
- 5300 Central Parkway, Dublin, CA, United States, 94568
- Owner or operator
- Carl Zeiss Meditec AG (Jena) (9053564)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 2, 1992
- Registered through
- 2026
- Brand names listed
- Atlas model 9000, CIRRUS HD-OCT 500, CIRRUS HD-OCT 5000, CIRRUS HD-OCT Model 400, 4000, CIRRUS HD-OCT Model 500, CIRRUS HD-OCT Model 500, 5000, CIRRUS HD-OCT Model 5000, CIRRUS HD-OCT Model 6000 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 17, 2025 | K243878 | CLARUS (700) | QER | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| May 17, 2024 | K233933 | CIRRUS HD-OCT Model 6000 | OBO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| April 13, 2023 | K222200 | CIRRUS HD-OCT | OBO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| June 25, 2019 | K191194 | CLARUS | QER | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| February 15, 2019 | K181534 | CIRRUS HD-OCT | OBO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| January 10, 2019 | K181444 | CLARUS | QER | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| June 8, 2018 | K180306 | Nexy | HKI | Substantially Equivalent | Next Sight Srl | accessdata.fda.gov |
| October 26, 2016 | K161194 | PLEX Elite 9000 SS-OCT | OBO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| September 1, 2015 | K150977 | CIRRUS HD-OCT | OBO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| February 27, 2015 | K141922 | IRIS INTELLIGENT RETINAL IMAGING SYSTEM | NFJ | Substantially Equivalent | Intelligent Retinal Imaging Systems, LLC | accessdata.fda.gov |
| January 19, 2012 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES | OBO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| August 10, 2009 | K082016 | GDX VCC WITH ECC SOFTWARE | MYC | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| May 5, 2009 | K083291 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 | OBO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| January 26, 2007 | K063378 | CIRRUS HD-OCT, MODEL 4000 | HLI | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| May 1, 2003 | K030433 | STRATUSOCT WITH RNFL NORMATIVE DATABASE | HLI | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| June 21, 1996 | K961171 | HUMPHREY OCT SCANNER | HLI | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
| November 24, 1995 | K954167 | HUMPHREY FIELD ANALYZER (HFA II) | HPT | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
| July 18, 1994 | K941705 | NERVE FIBER ANALYZER | HLI | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 14, 2022 | 89524 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 8, 2021 | 88109 | Class II | Ongoing | 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. | accessdata.fda.gov |
| December 6, 2018 | 83913 | Class II | Terminated | 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: | 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% a | accessdata.fda.gov |
| October 16, 2018 | 83229 | Class II | Terminated | 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 intende | 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. | accessdata.fda.gov |
| October 23, 2013 | 66635 | Class II | Terminated | 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. | 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. | accessdata.fda.gov |
| April 18, 2013 | 65109 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| October 25, 2012 | 63596 | Class II | Terminated | 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. | accessdata.fda.gov |
| September 26, 2011 | 60017 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| September 12, 2011 | 59908 | Not yet classified | Terminated | 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 pow | 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. | accessdata.fda.gov |
| July 1, 2011 | 59362 | Not yet classified | Terminated | 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 | accessdata.fda.gov |
| March 10, 2011 | 58313 | Not yet classified | Terminated | Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software. 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 | accessdata.fda.gov |
| July 31, 2009 | 52993 | Not yet classified | Terminated | Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 26600211 | Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS. | accessdata.fda.gov |
| May 18, 2009 | 52716 | Not yet classified | Terminated | VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany Medical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical area. Product Quant | Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment. | accessdata.fda.gov |
| June 3, 2004 | 29367 | Not yet classified | Terminated | Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye. | The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on the eye. Retinal bleeding and burns may result. | accessdata.fda.gov |
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Updated April 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.