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MARCO

TAKAGI SEIKO CO.,LTD. · Model MARCO ULTRA M2 BI · UDI-DI 04560323640940

HJO Prescription
1
510(k) clearances
215
Adverse events
8
Recalls
56
Facilities

Recalls

DateFirmReason
2021-04-15Haag-Streit USA IncExamination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
2020-12-07Carl Zeiss Meditec AGWhen 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 p
2018-06-25Carl Zeiss Meditec AGCalibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures
2016-07-01Nidek IncNidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
2015-10-27Carl Zeiss Meditec AGIOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
2015-10-27Carl Zeiss Meditec AGIOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
2013-10-23Carl 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
2013-10-23Carl 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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.