inforMED
MalfunctionFSO

OPMI VARIO

Received Feb 21, 2018 · Event occurred Jan 23, 2018

Report 7285400 · MDR key 7285400

Device

Generic name

Microscope, Surgical

Manufacturer

Carl Zeiss

Model number

OPMI VARIO

Product problems

  • Device Inoperable
  • Optical Problem

Patient

90 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THE BULB IN THE OR MICROSCOPE BURNED OUT. THE BACK-UP BULB WAS DIM AND SUB-OPTIMAL FOR DELICATE EYE CASES. THE EYE WAS ALREADY OPEN AND CATARACT/LENS REMOVED, SO IT COULD NOT BE CANCELLED/RE-SCHEDULED. THE BACKUP BULB IS IDENTICAL TO THE PRIMARY BULB AND SHOULD FUNCTION WITH THE SAME INTENSITY.