Data / Medical devices / Germany / Carl Zeiss Meditec AG (Jena)
Carl Zeiss Meditec AG (Jena): FDA-registered device maker in Jena Thuringia, Germany, 26 510(k) clearances and 1 PMA approval
Carl Zeiss Meditec AG (Jena) is registered with the FDA (registration 9615030) in Jena Thuringia, Germany. It lists 21 device types. The FDA files 26 510(k) clearances and 1 PMA approval under its listings, the newest dated May 31, 2017. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9615030
- FEI number
- 3001362763
- Address
- Carl-Zeiss-Promenade 10, Jena Thuringia, Germany, 07745
- Owner or operator
- Carl Zeiss Meditec AG (Jena) (9053564)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 2, 1992
- Registered through
- 2026
- Brand names listed
- ATLAS 500, CIRRUS Photo Models 600 and 800, CIRRUS photo Models 600 and 800, FF450 Plus VISUPAC System, Humphrey Lens Analyzer Series, IOL Master, IOL Master 700, IOLMASTER 500 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 |
|---|---|---|---|---|---|---|
| May 31, 2017 | K162684 | SL 220 | HJO | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| July 10, 2015 | K143275 | IOLMaster700 | HJO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| May 21, 2015 | K150467 | Retina Workplace | NFJ | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| September 9, 2014 | K141068 | ZEISS CATARACT SUITE MARKERLESS | HJO | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| March 19, 2014 | K133217 | CIRRUS PHOTO | OBO | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| February 12, 2014 | K133476 | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION | HJO | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| April 12, 2013 | K122418 | IOLMASTER 500 | HJO | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| June 18, 2012 | K112184 | CIRRUS PHOTO | OBO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| February 1, 2011 | K103056 | VISULAS TRION LASER SYSTEM WITH THE VITE OPTION | HQF | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| November 3, 2010 | K101182 | IOLMASTER 500 | HJO | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| March 17, 2010 | K100035 | MODEL VISULAS 532S LASER WITH THE VITE OPTION | GEX | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| September 21, 2007 | K072514 | VISULAS TRION | GEX | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| December 22, 2006 | K062314 | HORUS LASER KERATOME | GEX | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| November 2, 2005 | K052268 | VISUCAM PRO NM | HKI | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| February 14, 2005 | K043222 | VISCUCAM C DIGITAL CAMERA | HKI | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| September 9, 2004 | K042139 | VISULAS YAG III | GEX | Substantially Equivalent | Carl Zeiss Meditec, AG | accessdata.fda.gov |
| January 20, 2004 | K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | HKX | Substantially Equivalent | Reichert, Inc. | accessdata.fda.gov |
| November 14, 2001 | K013402 | VISULAS 532S | GEX | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
| September 26, 2001 | K011877 | FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM | HKI | Substantially Equivalent | Carl Zeiss Jena GmbH | accessdata.fda.gov |
| February 22, 2001 | K003885 | VISULAS YAG II | GEX | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
| March 20, 2000 | K993357 | IOLMASTER | HJO | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
| November 22, 1993 | K926452 | ZEISS VISULAS YAG II LASER | GEX | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
| September 9, 1993 | K925641 | ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR | HJO | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
| October 28, 1992 | K923341 | ZEISS VISULAS ARGON LASER | GEX | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
| June 17, 1986 | K862004 | ZEISS 30 SL-L | HJO | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
| October 4, 1985 | K853891 | INDIRECT OPHTHALMOSCOPE | HLJ | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 11, 2006 | P060004 | MEL 80 EXCIMER LASER SYSTEM | LZS | 9 | July 1, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 7, 2020 | 87055 | Class II | Terminated | 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 | accessdata.fda.gov |
| August 6, 2020 | 86366 | Class II | Terminated | 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. | accessdata.fda.gov |
| June 25, 2018 | 81000 | Class II | Terminated | 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. | accessdata.fda.gov |
| October 27, 2015 | 72564 | Class II | Terminated | 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. | accessdata.fda.gov |
| January 22, 2015 | 70365 | Class II | Terminated | 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 eithe | Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data. | accessdata.fda.gov |
| February 3, 2014 | 67440 | Class II | Terminated | 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 un | Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. | accessdata.fda.gov |
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Updated July 1, 2026. 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.