Jena, DE · 20 510(k) clearances · 26 PMAs · 7 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | Class II | Radiology | 4 | 2026-07-17 |
| HQF | — | — | — | 3 | 2024-09-06 |
| OBO | Tomography, Optical Coherence | Class II | Ophthalmic | 3 | 2024-05-17 |
| HQC | — | — | — | 3 | 2023-07-31 |
| QFX | Diagnostic Neurosurgical Microscope Filter | Class II | Neurology | 2 | 2024-06-28 |
| QER | — | — | — | 1 | 2025-04-17 |
| JAD | System, Therapeutic, X-Ray | Class II | Radiology | 1 | 2025-01-10 |
| GWG | — | — | — | 1 | 2023-09-21 |
| IZI | — | — | — | 1 | 2023-06-20 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2021-12-29 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-07-01 | P060004-S010 | MEL 90 Excimer Laser | Real-Time Process | LZS | Excimer Laser System | Unknown |
| 2026-05-26 | P150040-S024 | VISUMAX 800 Femtosecond Laser | Real-Time Process | OTL | — | — |
| 2026-05-20 | P150040-S025 | Visumax Femtosecond Laser | 30-Day Notice | OTL | — | — |
| 2026-04-30 | P060004-S011 | MEL 90 Excimer Laser | 30-Day Notice | LZS | Excimer Laser System | Unknown |
| 2025-12-18 | P150040-S020 | VisuMax; VISUMAX 800 | Normal 180 Day Track No User Fee | OTL | — | — |
| 2025-10-16 | P150040-S023 | VISUMAX 800 Femtosecond Laser | 30-Day Notice | OTL | — | — |
| 2025-08-21 | P150040-S021 | Visumax; VISUMAX 800 | 30-Day Notice | OTL | — | — |
| 2025-05-23 | P060004-S009 | MEL 90 EXCIMER LASER SYSTEM | Real-Time Process | LZS | Excimer Laser System | Unknown |
| 2024-12-04 | P060004-S006 | MEL90 | Panel Track | LZS | Excimer Laser System | Unknown |
| 2024-10-16 | P150040-S018 | VisuMax Femtosecond Laser | Real-Time Process | OTL | — | — |
| 2024-10-11 | P150040-S016 | VisuMax | 135 Review Track For 30-Day Notice | OTL | — | — |
| 2024-05-23 | P150040-S017 | VisuMax | 30-Day Notice | OTL | — | — |
| 2024-03-18 | P150040-S015 | VisuMax & VISUMAX 800 | 30-Day Notice | OTL | — | — |
| 2024-03-13 | P060004-S007 | MEL 80 Excimer Laser | Real-Time Process | LZS | Excimer Laser System | Unknown |
| 2024-01-10 | P150040-S012 | VISUMAX 800 | Normal 180 Day Track | OTL | — | — |
| 2023-08-15 | P150040-S014 | VisuMax Femtosecond Laser Accessory Treatment Pack | 30-Day Notice | OTL | — | — |
| 2023-04-13 | P150040-S013 | VisuMax Femtosecond Laser | Normal 180 Day Track No User Fee | OTL | — | — |
| 2023-02-16 | P060004-S005 | MEL 80 Excimer Laser System | 30-Day Notice | LZS | Excimer Laser System | Unknown |
| 2023-02-16 | P060004-S004 | MEL 80 Excimer Laser System | 30-Day Notice | LZS | Excimer Laser System | Unknown |
| 2022-12-21 | P150040-S011 | VisuMax Femtosecond Laser | 30-Day Notice | OTL | — | — |
| 2022-06-17 | P150040-S010 | VisuMax Femtosecond Laser | 30-Day Notice | OTL | — | — |
| 2021-02-24 | P150040-S009 | VisuMax Femtosecond Laser | 30-Day Notice | OTL | — | — |
| 2021-02-19 | P150040-S008 | VisuMax Femtosecond Laser | Normal 180 Day Track | OTL | — | — |
| 2020-11-23 | P150040-S007 | VisuMax Femtosecond Laser | 30-Day Notice | OTL | — | — |
| 2020-10-07 | P150040-S006 | VisuMax Femtosecond Laser | 30-Day Notice | OTL | — | — |
| 2020-04-02 | P150040-S005 | VisuMax Femtosecond Laser | 30-Day Notice | OTL | — | — |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-06-01 | Class II | Ongoing | Z-2649-2026 | Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 | — | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. |
| 2022-03-16 | Class II | Ongoing | 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. |
| 2022-01-14 | Class II | Ongoing | 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. |
| 2021-07-08 | Class II | Ongoing | 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… |
| 2020-12-07 | Class II | Terminated | 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… |
| 2020-08-06 | Class II | Terminated | Z-0614-2021 | Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objectiv… | — | Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guarantee… |
| 2020-08-06 | 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 conta… | — | Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guarantee… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-17 | K260694 | ZEISS CLINIC 360 | NFJ | Class II | Radiology |
| 2025-04-17 | K243878 | CLARUS (700) | QER | — | — |
| 2025-01-10 | K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | JAD | Class II | Radiology |
| 2024-09-06 | K233911 | VISULAS combi | HQF | — | — |
| 2024-06-28 | K240215 | BLUE 400; BLUE 400 S | QFX | Class II | Neurology |
| 2024-05-17 | K233933 | CIRRUS HD-OCT Model 6000 | OBO | Class II | Ophthalmic |
| 2024-03-08 | K233421 | RESCAN 700 | OBO | Class II | Ophthalmic |
| 2023-12-21 | K232944 | CALLISTO eye | NFJ | Class II | Radiology |
| 2023-10-24 | K232051 | VISULAS green | HQF | — | — |
| 2023-09-22 | K230350 | VISULAS yag | HQF | — | — |
| 2023-09-21 | K232159 | QEVO System | GWG | — | — |
| 2023-08-28 | K231676 | CALLISTO eye | NFJ | Class II | Radiology |
| 2023-07-31 | K230858 | QUATERA 700 | HQC | — | — |
| 2023-06-20 | K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | IZI | — | — |
| 2023-04-13 | K222200 | CIRRUS HD-OCT | OBO | Class II | Ophthalmic |
| 2022-08-15 | K213527 | FORUM | NFJ | Class II | Radiology |
| 2022-07-22 | K211346 | BLUE 400 | QFX | Class II | Neurology |
| 2022-04-19 | K212241 | QUATERA 700 | HQC | — | — |
| 2021-12-29 | K211156 | CONVIVO In Vivo Pathology Suite | LLZ | Class II | Radiology |
| 2020-06-15 | K193376 | Visalis V500, Visalis S500 | HQC | — | — |