OPMI LUMERA 700

Additional Manufacturer Narrative

* D4: ADDED MODEL NUMBER 700; ADDED SERIAL NUMBER (B)(6). * H3: DEVICE EVALUATED BY MANUFACTURER? CHANGED FROM NO, TO YES. * H6: TYPE OF INVESTIGATION: ADDED 10, TESTING OF ACTUAL/SUSPECTED DEVICE; INVESTIGATION FINDINGS: CHANGED FROM 3233, RESULTS PENDING COMPLETION OF INVESTIGATION, TO 213, NO DEVICE PROBLEM FOUND; INVESTIGATION CONCLUSIONS: CHANGED FROM 11, CONCLUSION NOT YET AVAILABLE, TO 4316, APPROPRIATE TERM/CODE NOT AVAILABLE. SUGGESTED CODE IS "TEMPORARY ERROR." * MANUFACTURER NARRATIVE: THE ISTENT PORTION OF THE SURGERY IS NOT CRITICAL, AS THE MAIN FOCUS IS CATARACT SURGERY. ABORTING THE ISTENT DOES NOT POSE SERIOUS INJURY RISKS BUT MAY LEAD TO MORE TREATMENTS FOR MANAGING INTRAOCULAR PRESSURE (IOP). THE ISTENT IS PART OF THE SURGICAL GOAL. MICROINVASIVE GLAUCOMA SURGERY (MIGS), LIKE ISTENT, IS OFTEN DONE WITH CATARACT SURGERY TO LOWER IOP. WITHOUT IT, ADDITIONAL TREATMENTS MAY BE NEEDED LATER. MIGS CAN ALSO BE PERFORMED SAFELY AS STANDALONE PROCEDURES. THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPRODUCE THE ERROR. UPON INVESTIGATING THE LOG FILES, IT WAS FOUND THAT A SINGLE ERROR WAS RECORDED ON THE DATE OF THE INCIDENT: A COMMUNICATION ERROR WITH THE OPMI BOARD. AFTER RESTARTING, ALL FUNCTIONS RESUMED WITHOUT ANY ISSUES. A THOROUGH SEARCH OF THE LOGS REVEALED NO FURTHER OCCURRENCES OF THE ERROR. BASED ON THE DATA AND INFORMATION PROVIDED, IT SEEMS THAT THE DEVICE EXPERIENCED A TEMPORARY ERROR, WITH NO RECURRING PATTERNS OR NEGATIVE IMPACT ON ITS FUNCTIONALITY. THE DEVICE IS OPERATING WITHIN NORMAL PARAMETERS. THE ISSUE DOESN'T PRESENT ANY SYSTEMATIC. CASE WAS DOCUMENTED IN MANUFACTURERS DATABASE AND WILL CONTINUE TO BE MONITORED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A CATARACT EXTRACTION AND ISTENT IMPLANTATION SURGERY, THE THUMBWHEEL FOR THE MOTORIZED TILT FAILED ON THE OPMI LUMERA 700, LEADING TO THE ABORTION OF THE ISTENT PROCEDURE. THE STATUS OF THE PATIENT IS POSITIVE, WITH IMPROVED VISION AND CONTROLLED INTRAOCULAR PRESSURE USING EYE DROPS, AND DOES NOT REQUIRE ADDITIONAL SURGICAL INTERVENTION AT THIS TIME. HOWEVER, THERE IS A HIGHER LIKELIHOOD THAT SEPARATE OR ADDITIONAL TREATMENT, OR MORE EYE DROPS TO LOWER INTRAOCULAR PRESSURE (IOP), MAY BE NECESSARY.