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Carl Zeiss Meditec AG Recalls
11 recalls on record · March 19, 2014 to July 8, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 8, 2026Medical DevicesFDA
Carl Zeiss Meditec AG recalls Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Hazard: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
May 4, 2022Medical DevicesFDA
Carl Zeiss Meditec AG recalls ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Hazard: High friction of the slider can cause the device to stick, or not move as intended.
February 24, 2021Medical DevicesFDA
Carl Zeiss Meditec AG recalls IOLMaster 700
Hazard: 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
December 23, 2020Medical DevicesFDA
Carl Zeiss Meditec AG recalls Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objectiv
Hazard: 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.
December 23, 2020Medical DevicesFDA
Carl Zeiss Meditec AG recalls Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of conta
Hazard: 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.
October 24, 2018Medical DevicesFDA
Carl Zeiss Meditec AG recalls Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09
Hazard: 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.
October 11, 2017Medical DevicesFDA
Carl Zeiss Meditec AG recalls Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germ
Hazard: The device had an incorrect printed calibration value on the calibration certificate.
December 9, 2015Medical DevicesFDA
Carl Zeiss Meditec AG recalls IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of
Hazard: IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
December 9, 2015Medical DevicesFDA
Carl Zeiss Meditec AG recalls IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculation
Hazard: IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
February 11, 2015Medical DevicesFDA
Carl Zeiss Meditec AG recalls 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). Cat
Hazard: Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.
March 19, 2014Medical DevicesFDA
Carl Zeiss Meditec AG recalls Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany.
Hazard: Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.