OPMI® LUMERA® 300 6137Recalls & reported problems
Carl Zeiss Suzhou Co., Ltd. · No description · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06909262061375), received between Jun 2, 2023 and Jun 2, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Recalls naming this device
- Aug 18, 2023Open, Classified
Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.
Z-0183-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER FROM INDIA REPORTED THAT THE OPMI WITH XY CAME LOOSE FROM THE SUSPENSION ARM WHEN CUSTOMER MOVED THE MICROSCOPE. NO PATIENT WAS INVOLVED AND NO ONE WAS INJURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17055591 ↗
Other Microscope, Surgical, General & Plastic Surgery devices
- AESCULAP PV010Aesculap AG · MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY3 recalls8 reports
- M220 F12 000000000010448367Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- KINEVO® 900 6640Carl Zeiss Meditec AG · Microscope, Surgical, General & Plastic Surgery1 death1 report
- M844 F40 / M822 F40 000000000010448142Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY1 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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