Home › Device types › HRM
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
FDA product code HRM · Class 1 · General, Plastic Surgery
221
Registered devices
374
Adverse events
7
Recalls
14
510(k) clearances
Devices with this code
Precision Mount for Alcon — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMicroscope Cover MITAKA 137/380 HLT — PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.SDI 4c for motorized focus of BIOM 4c(l) — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungUNITY — Alcon Laboratories, Inc.Microscope Cover MITAKA mm80, mm90, 80/276 — PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.OPMI Lumera 700 — Carl Zeiss Meditec AGLeica RUV800 WD200 — Leica Microsystems (Schweiz) AGARTEVO 750/850 — Carl Zeiss Meditec AGMicroscope Cover ZEISS "MD" 115/180 6.50 — PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.Mediworks — SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.TV RELAY LENS TL-6A — TOPCON CORPORATIONLabomed Stella OPH microscope with wall mount — LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDHS Hi-R NEO 900 Microscope — Haag-Streit AGMS DRAPE For Zeiss W/HLT ANGLE LENS 45”x118”, 115x300cm — PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.LuxOR — Alcon Laboratories, Inc.BEAM SPLITTER MS-BS03-50/50 — TOPCON CORPORATIONInverter Vitrectomy System Set For Leica Type Microscopes — OCULAR INSTRUMENTS, INC.Landers Lens Forceps — OCULAR INSTRUMENTS, INC.SDI 4b Zeiss — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHiRes lens for BIOM 5 — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMicroscope Cover LEICA 115/300 w Rubber, 7 HLT — PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.INAMI — INAMI & CO., LTD.Peyman-Wessels-Landers 132D Upright Vitrectomy Lens — OCULAR INSTRUMENTS, INC.BIOM Connecting Spacer — 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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