OPMI LUMERA 700
Received Jul 6, 2026 · Event occurred May 27, 2026
Report 9615010-2026-00008 · MDR key 25725356
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
700Catalog number
305953-9905-000
Product problems
- Unexpected Shutdown
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT DURING EYE SURGERY ON A CHILD, THE LAMP OF THE OPMI LUMERA 700 SUDDENLY SHUT DOWN. THE EXACT TYPE OF EYE SURGERY IS NOT KNOWN. THE CUSTOMER CONTACTED THE LOCAL FIELD SERVICE ENGINEER, WHO ATTEMPTED TO TROUBLESHOOT THE ISSUE REMOTELY AND GUIDED THE RESPONSIBLE BIOMED BY PHONE. THEY TRIED SHUTTING DOWN THE SYSTEM AND RESTARTING IT, SWITCHING TO ANOTHER LAMP, AND CONNECTING TO LED ILLUMINATION; HOWEVER, NONE OF THESE MEASURES WERE SUCCESSFUL. AS A RESULT, THE SURGERY HAD TO BE INTERRUPTED, AND THE CHILD HAD TO BE BROUGHT OUT OF AMNESIA. THE EVENT TOOK PLACE IN SWEDEN.