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IOLMaster 500
Carl Zeiss Meditec AG · Model IOLMaster 500 · UDI-DI 04049471092066
2
510(k) clearances
217
Adverse events
8
Recalls
57
Facilities
Description
The IOLMaster is intended for the biometric determination of ocular measurements for axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.
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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Get your free API keyRead the docsData 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.