Home › Device types › HRM
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
FDA product code HRM · Class 1 · General, Plastic Surgery
218
Registered devices
366
Adverse events
7
Recalls
14
510(k) clearances
Devices with this code
PROCAM HD 2D — EclerisSDI 4e electrically — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungVS3-MMS — VISIONSENSE LTD.OPMI Lumera 700 — Carl Zeiss Meditec AGMOPTIM — Shenzhen CERTAINN Technology Co., Ltd.SeeLuma Binoculars — Munich Surgical Imaging GmbHMicroscope Cover LEICA 115/210 W/DRAWSTRING HLT — PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.SDI 4m mechanically — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMicroscope Cover ZEISS 137/380 6.50 — PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.TV RELAY LENS TL-7A — TOPCON CORPORATIONMitaka MM51 cover — PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.Adapter plate for ZEISS RESIGHT for BIOM 5m/ BIOM 5ml/BIOM ready — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungSeeLuma — Munich Surgical Imaging GmbHMicroscope Cover MITAKA mm80, mm90, 80/266 — PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.Inverter Vitrectomy System Set For Leica Type Microscopes — OCULAR INSTRUMENTS, INC.RESIGHT metal tray — Carl Zeiss Meditec AGINAMI — INAMI & CO., LTD.SDI 4e, Stereo Diagonal Inverter electrically switched for Kaps — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungPROCAM HD 2D — EclerisRUV800 WD175 — Leica Microsystems (Schweiz) AGSingle-use lenses for RESIGHT, ULTRA WIDE-ANGLE LENS — Carl Zeiss Meditec AGSeeLuma Digital Binoculars Module — Munich Surgical Imaging GmbHPrecision Mount for Zeiss — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungDovetail for BIOM — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-21 | Leica Microsystems, Inc. | There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the over |
| 2020-11-20 | Haag-Streit USA Inc | Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the |
| 2019-01-02 | Leica Microsystems, Inc. | The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. |
| 2018-07-17 | Alcon Research Laboratories Ltd. | Potential for the optical head to detach from the stand due to the lack of thread adhesive. |
| 2017-09-25 | Leica Microsystems, Inc. | The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic |
| 2017-05-25 | Alcon Research, Ltd. | Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detac |
| 2015-08-11 | Alcon Research, Ltd. | Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cablin |
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