OMNI EDGE SURGICAL SYSTEM
Received Jul 22, 2026 · Event occurred Jun 25, 2026
Report 3010363671-2026-00010 · MDR key 25900008
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Intraocular Pressure Decreased
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
THE PHYSICIAN WHO PERFORMED THE OMNI PROCEDURE REPORTED ENCOUNTERING SOME RESISTANCE DURING THE PROCEDURE; HOWEVER, HE WAS ABLE TO REPOSITION THE DEVICE AND SUCCESSFULLY COMPLETE THE TREATMENT. HE NOTED BLEEDING DURING RETRACTION, WHICH APPEARED CONSISTENT WITH THE BLEEDING ROUTINELY OBSERVED DURING A GONIOTOMY.AT THE POSTOPERATIVE DAY 1 FOLLOW-UP VISIT, THE PATIENT PRESENTED WITH A SUBSTANTIAL HEMORRHAGE, AN INTRAOCULAR PRESSURE (IOP) OF 4 MMHG, AND A CYCLODIALYSIS CLEFT. CYCLOPLEGIC THERAPY WAS PRESCRIBED. AT A SUBSEQUENT FOLLOW-UP,THE IOP WAS 33MMHG AND GLAUCOMA MEDICATIONS WERE STARTED, THE VITREOUS HEMORRHAGE HAD ESSENTIALLY RESOLVED, ALONG WITH THE CHOROIDAL EFFUSIONS. NO OBVIOUS CYCLODIALYSIS CLEFT WAS IDENTIFIED ON EXAMINATION, SUGGESTING THAT THE CLEFT WAS EITHER VERY SMALL OR HAD CLOSED SPONTANEOUSLY. AT THE RECENT FOLLOW UP , THE IOP WAS DOWN TO 15MMHG.