M530 Optics Carrier 000000000010448704Recalls & reported problems
Leica Microsystems (Schweiz) AG · M530 Optics Carrier for ULT 530 - for Leica surgical operating microscope systems: ARveo, PROvido, M530 OHX, M530 OH6 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630003577112), received between Oct 3, 2023 and Jan 17, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem3
- Adverse Event Without Identified Device or Use Problem1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM SPAIN STATING THAT A PROVIDO HAD A LOSS OF FUNCTION DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178139 ↗MalfunctionSep 13, 2024Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem
LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM GERMANY STATING THAT THE FILTER WHEEL OF A M530 OHX HAD JAMMED DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20212028 ↗MalfunctionSep 6, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM JAPAN STATING THAT AN M530 OHX HAD A LOSS OF ILLUMINATION DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20154806 ↗MalfunctionOct 3, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM USA STATING THAT A M530 OHX HAD A LOSS OF FUNCTION DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860541 ↗
Other MICROSCOPE, SURGICAL devices
- PROvido 000000000010448950Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL3 reports
- M530 OHX 000000000010448737Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL3 reports
- PROvido 000000000010448976Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL2 reports
- M525 F20 000000000010448284Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL2 reports
- IMAGE1 PILOT TC014Karl Storz GmbH & Co. KG · MICROSCOPE, SURGICAL2 reports
- M530 Optics Carrier 000000000010448700Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL1 report
- 1788 1788210080Stryker Corporation · Microscope, surgical1 report
- ARveo 000000000010448999Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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