Carl Zeiss Meditec, Inc.
FDA Regulatory Profile
Carl Zeiss Meditec, Inc. appears in FDA public data with 21 recalls, 76 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2649-2026, Class II) was initiated on June 1, 2026. Its most recent 510(k) clearance was granted on July 17, 2026.
Summary
- Total Recalls
- 21
- 510(k) Clearances
- 76
- Inspections
- 9
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2649-2026 | Class II | Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 | June 1, 2026 |
| Z-1007-2022 | Class II | ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery. | March 16, 2022 |
| Z-0723-2022 | Class II | CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex | January 14, 2022 |
| Z-2227-2021 | Class II | Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000" | July 8, 2021 |
| Z-1133-2021 | Class II | IOLMaster 700 | December 7, 2020 |
| Z-0613-2021 | Class II | Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refra | August 6, 2020 |
| Z-0614-2021 | Class II | Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to de | August 6, 2020 |
| Z-0680-2020 | Class II | VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunc | December 6, 2018 |
| Z-0770-2020 | Class II | The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source | October 16, 2018 |
| Z-0108-2019 | Class II | Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 | June 25, 2018 |
| Z-0001-2018 | Class II | Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Me | August 30, 2017 |
| Z-0358-2016 | Class II | IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometr | October 27, 2015 |
| Z-0357-2016 | Class II | IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and | October 27, 2015 |
| Z-1049-2015 | Class II | 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 | January 22, 2015 |
| Z-1153-2014 | Class II | Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG | February 3, 2014 |
| Z-0334-2014 | Class II | Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactu | October 23, 2013 |
| Z-0333-2014 | Class II | Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufacture | October 23, 2013 |
| Z-1440-2013 | Class II | Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numb | April 18, 2013 |
| Z-0405-2013 | Class II | INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM | October 25, 2012 |
| Z-0404-2013 | Class II | INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM | October 25, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260694 | ZEISS CLINIC 360 | July 17, 2026 |
| K243878 | CLARUS (700) | April 17, 2025 |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRA | January 10, 2025 |
| K233911 | VISULAS combi | September 6, 2024 |
| K240215 | BLUE 400; BLUE 400 S | June 28, 2024 |
| K233933 | CIRRUS HD-OCT Model 6000 | May 17, 2024 |
| K233421 | RESCAN 700 | March 8, 2024 |
| K232944 | CALLISTO eye | December 21, 2023 |
| K232051 | VISULAS green | October 24, 2023 |
| K230350 | VISULAS yag | September 22, 2023 |
| K232159 | QEVO System | September 21, 2023 |
| K231676 | CALLISTO eye | August 28, 2023 |
| K230858 | QUATERA 700 | July 31, 2023 |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | June 20, 2023 |
| K222200 | CIRRUS HD-OCT | April 13, 2023 |
| K213527 | FORUM | August 15, 2022 |
| K211346 | BLUE 400 | July 22, 2022 |
| K212241 | QUATERA 700 | April 19, 2022 |
| K211156 | CONVIVO In Vivo Pathology Suite | December 29, 2021 |
| K193376 | Visalis V500, Visalis S500 | June 15, 2020 |