Microscope, Operating & Accessories, Ac-powered, Ophthalmic
General, Plastic Surgery · 21 CFR 878.4700
Recent MDR events
366 adverse event reports on file
- LuxOR Ophthalmic MicroscopesJul 30, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-01168
- LUXOR OPHTHALMIC MICROSCOPESJul 22, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-01103
- LUXOR OPHTHALMIC MICROSCOPESJul 19, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-01094
- OPMI VISU 200Jul 10, 2026InjuryCarl Zeiss Meditec Ag (oberkochen)9615010-2026-00012
- LUXOR OPHTHALMIC MICROSCOPESJul 8, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-00996
- LUXOR OPHTHALMIC MICROSCOPESJul 7, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-00993
- LUXOR OPHTHALMIC MICROSCOPESJun 10, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-00824
- LUXOR OPHTHALMIC MICROSCOPESMay 8, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-00655
- LUXOR OPHTHALMIC MICROSCOPESApr 20, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-00528
- LUXOR OPHTHALMIC MICROSCOPESApr 9, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-00465
Event type breakdown
Recalls
7 recall events for this product code
- Leica Microsystems, Inc.Open, ClassifiedDec 9, 2022
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
Z-0475-2023 · View FDA record ↗ - Alcon Research Laboratories Ltd.TerminatedFeb 27, 2019
Alcon or Endure Ophthalmic Microscope
Potential for the optical head to detach from the stand due to the lack of thread adhesive.
Z-0961-2019 · View FDA record ↗ - Alcon Research, Ltd.TerminatedAug 21, 2015
LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue.
Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure.
Z-2448-2015 · View FDA record ↗ - Haag-Streit USA IncOpen, ClassifiedUnknown
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no
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 movement does not stop when releasing the button, result in potential risk to the patient's eye
Z-0697-2021 · View FDA record ↗ - Leica Microsystems, Inc.TerminatedUnknown
Leica M220 F12 surgical microscope
The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
Z-0772-2019 · View FDA record ↗ - Leica Microsystems, Inc.TerminatedUnknown
PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for
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 failures in the proper on-screen display functionality of the HDR recording unit. Additionally, an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.
Z-0838-2019 · View FDA record ↗ - Alcon Research, Ltd.TerminatedUnknown
LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope.
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 detaching from the base.
Z-3081-2017 · View FDA record ↗
Registered firms
60 firms currently registered for this product code
Karl Kaps Gmbh & Co. Kg
ASSLAR Hesse, DE
P Bhogilal Pvt Ltd
Kolkata West Bengal, IN
Ocular Instruments, Inc.
BELLEVUE, WA, US
Shanghai Link Instruments Co.,ltd
Changzhou City Jiangsu, CN
Accutome, Inc.
Malvern, PA, US
Munich Surgical Imaging Gmbh
Munich Bavaria, DE
Carl Zeiss Meditec Ag (jena)
JENA Thuringia, DE
Takagi Seiko Co., Ltd.
NAKANO-SHI Nagano, JP
Pharmasept Ltd. Medical Products
Caesarea Central, IL
Topcon Corp.
TOKYO, JP
Suzhou Raish Meditech Co., Ltd
Suzhou Jiangsu, CN
Alcon Research, Llc
IRVINE, CA, US
Eyevis Mediworks Private Limited
Ahmedabad Gujarat, IN
Appasamy Associates Private Limited ( Thruvandar Koil)
Mannadipet Commune Puducherry, IN
Carl Zeiss Meditec Ag (oberkochen)
OBERKOCHEN Baden-Wurttemberg, DE
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Ming Fai Industrial (shenzhen) Co. Ltd.
SHENZHEN Guangdong, CN
Sterigenics U.s., Llc
Atlanta, GA, US
Labo America
Fremont, CA, US
Carl Zeiss Meditec Ag (munich)
Muenchen Bavaria, DE
Beijing Hongdee Corporation
Beijing, CN
Shanghai Mediworks Precision Instruments Co., Ltd.
Shanghai, CN
Leica Instruments (singapore) Pte Ltd.
SINGAPORE South West, SG
Aspen Surgical Products, Inc.
Caledonia, MI, US
Fedex Supply Chain, Inc.
Memphis, TN, US
510(k) clearances
14 clearances for this product code
- Hill-Med, Inc.Sep 7, 1993
K932720 · HM-0970
- Marco Ophthalmic, Inc.Jul 22, 1993
K930439 · MARCO SURGISCOPE OPERATION MICROSCOPES
- Alcon LaboratoriesOct 9, 1992
K920641 · ALCON OPERATING MICROSCOPES
- Keeler Instruments, Inc.Feb 3, 1992
K914956 · KEELER KONAN SPECULAR MICROSCOPE SP5500
- Carl Zeiss, Inc.Jun 8, 1989
K891584 · S 22 INSTRUMENT STAND
- Prescott'S, Inc.Apr 11, 1989
K891001 · MICROSCOPE KNOB COVER, STERILE, DISPOSABLE
- Keeler Instruments, Inc.Dec 16, 1985
K854440 · MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50
- Xtal Corp.Oct 15, 1985
K853855 · XTAL X-150 OPERATING MICROSCOPE