RESCAN 700

Description of Event or Problem

A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT AN ISSUE OCCURRED DURING A GLAUCOMA AND CATARACT SURGERY, INVOLVING THE OPMI LUMERA 700, RESCAN 700, AND CALLISTO EYE. ACCORDING TO THE REPORT, THE SURGERY BEGAN WITH THE MICROSCOPE PROVIDING CORRECT VISUALIZATION AND BRIGHTNESS. THE CAPSULORHEXIS WAS PERFORMED WITHOUT ISSUE. DURING THE PHACOEMULSIFICATION, THE LIGHT POWER AND BRIGHTNESS FROM THE MICROSCOPE WERE LOST. DUE TO POOR VISUALIZATION, A POSTERIOR CAPSULAR RUPTURE OCCURRED, AND FRAGMENTS OF THE EPINUCLEUS AND CORTEX WERE DISLOCATED INTO THE VITREOUS CAVITY. AN ANTERIOR VITRECTOMY WAS PERFORMED, AND A LENS WAS IMPLANTED IN THE CILIARY SULCUS, BUT WITH VERY POOR VISIBILITY TO COMPLETE THE SURGERY. THE LABORATORY PERSONNEL REPRESENTING THE MICROSCOPE EXPLAINED THAT THE STARTUP PROTOCOL HAD BEEN FOLLOWED CORRECTLY. THE PATIENT HAS HAD TO UNDERGO RE-OPERATION TWICE, AND HAS HAD VERY HIGH IOPS (EYE PRESSURE). THE DOCTOR IS WAITING TO SEE IF THE PATIENT ULTIMATELY LOSES TOO MUCH VISION IN THE PATIENT'S ONE AFFECTED EYE FOR ANY FURTHER INTERVENTION. THE ROOT CAUSE CANNOT BE DETERMINED YET DUE TO LACK OF FURTHER INFORMATION. FURTHER INVESTIGATION IS REQUIRED AND IS IN PROGRESS.

Additional Manufacturer Narrative

RELATED REPORTS: CALLISTO EYE: 3009746052-2025-00001. OPMI LUMERA 700: 9615010-2025-00014.