Microscope, Surgical

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2022-12-09Open, ClassifiedProcess control

  Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). 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.

• 2022-12-09Open, ClassifiedProcess control

  Leica MICROSYSTEMS M530 OHX, Part Number 10448737, 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.

• 2018-09-14TerminatedDevice Design

  Leica M525 F20 Surgical Microscope System

  The firm received complaints that the instrument tipped over when the swing arm was fully extended.

• 2013-05-31TerminatedUnder Investigation by firm

  Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

  Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount.

• 2011-10-24TerminatedNonconforming Material/Component

  OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.

  An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations.

• 2011-09-23TerminatedPending

  OPMI Pentero, OPMI Pentero C, OPMI Pentero 900, OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro Multivision/NC4, OPMI Vario/NC33, OPMI Neuro/NC4, OPMI Neuro/NC4 Ceiling Mount. A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area.

  Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems.

• 2011-01-14TerminatedLabeling mix-ups

  VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany Medical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical area. Product Quantity Distributed (Int) 2540 units

  Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.

• 2006-06-24TerminatedOther

  Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Multi-Foc variable objective lens with diameter and light intensity of illuminated field continuously adjustable and high power 300W xenon lamp (both main and back-up illimuniation) through fiber optic cable; Leica Microsystems (Schweiz) AG, Business Unit SOM, Max Schmidheiny-Strasse 201, CH-9435 Heerbrugg, Switzerland; Leica Microsystems Inc., 90 Boroline Road, Allendale, NJ 07401; Leica Microsystems Inc., 2345 Waukegan Road, Bannockburn, IL 60015-9792 The M520 microscope was sold with the following floor stands to form Leica Surgical Microscope Systems: a) MS-1 floor stand with manual balancing for the microscope carrier in three axes and three electromagnetic and mechanical brakes; b) MS-2 floor stand with 3 step balancing for the optical head, autobalance for the floor stand and six electromagnetic brakes; c) MS-3 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: 1456 mm d) ) OHS1 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, e) OH3 floor stand with fully-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: Max. 1520 mm f) F40 floor stand with continuously adjustable balancing system and four electromagnetic permanent magnetic brakes, Maximum reach 1496 mm

  Patient Burns-The use of the surgical microscope at high light intensity and short working distances can result in patient burns.

• Open, ClassifiedUse error

  Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.

  The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.

• TerminatedOther

  Leica ARveo and M530 OH6 microscope systems.

  Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.