inforMED
InjuryFSO

OPMI LUMERA T

Received Dec 10, 2024 · Event occurred Nov 13, 2024

Report 9615010-2024-00009 · MDR key 20888682

Device

Generic name

Microscope, Surgical, General & Plastic Surgery

Product problems

  • Mechanical Jam
  • Optical Problem
  • Mechanical Jam
  • Optical Problem

Patient

NA · Unknown

  • Visual Impairment
  • Visual Impairment

Narrative

Description of Event or Problem

A HEALTH CARE PROFESSIONAL (HCP) REPORTED AN ISSUE DURING A VITRECTOMY PROCEDURE INVOLVING LENS DISLOCATION IN THE LEFT EYE. THE OPMI LUMERA T RESIGHT IMAGE WOULD NOT INVERT, WHEN IT WAS SLID INTO PLACE. THE SURGEON WAS INSTRUCTED TO MANUALLY INVERT THE IMAGE, BUT THE MECHANISM WAS STIFF AND COULD NOT FULLY INVERT THE TUBE, PREVENTING PROPER VISUALIZATION. THE SURGEON ATTEMPTED TO USE A LANDER LENS, BUT THIS EFFORT WAS UNSUCCESSFUL AND RESULTED IN AN ADDITIONAL HOUR OF DELAY FOR THE PROCEDURE. ULTIMATELY, THE OPERATION WAS CONCLUDED USING A DIFFERENT DEVICE; HOWEVER, THE PLANNED SURGICAL OBJECTIVE WAS NOT ACHIEVED. AS A RESULT, THE PATIENT WILL REQUIRE FURTHER SURGERY TO CORRECT THE LENS DISLOCATION AND RETINAL DETACHMENT.