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IOLMaster 700

Carl Zeiss Meditec AG · Model IOLMaster 700 · UDI-DI 04049471092080

HJO

510(k) clearances

217

Adverse events

Recalls

Facilities

Description

The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures: • Lens thickness • Corneal curvature and thickness • Axial length • Anterior chamber depth • Pupil diameter • White-to-white distance (WTW) For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

Recalls

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