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Chongqing Kanghuaruiming S&T Co., Ltd.. · Model SLM-2ER · UDI-DI 06951214400022

HJO Prescription

510(k) clearances

217

Adverse events

Recalls

Facilities

Description

The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. The KH Ophthalmic Slit-lamp Microscope is composed of the following components: microscope unit, illumination unit, base unit, chinrest, and table and power unit. The slit-lamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.

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.