THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE DEVICE LABELING PROVIDES THE FOLLOWING INSTRUCTIONS: THE MICROSTENT IMPLANTATION PROCEDURE SHOULD BE PERFORMED AFTER COMPLETION OF CATARACT EXTRACTION AND INTRAOCULAR LENS IMPLANTATION. IT IS IMPORTANT TO COMPLETELY REMOVE OVD FROM INSIDE THE BAG AND FROM BEHIND THE IRIS BEFORE PROCEEDING WITH HYDRUS IMPLANTATION. A HIGH MOLECULAR WEIGHT COHESIVE VISCOELASTIC IS RECOMMENDED. ELEVATED IOP IS LISTED IN THE DEVICE LABELING AS A POTENTIAL ADVERSE EVENT. (B)(4).
D
Patient 1
A PATIENT UNDERWENT UNEVENTFUL CATARACT SURGERY WITH IMPLANTATION OF THE HYDRUS MICROSTENT ON (B)(6) 2019. ON (B)(6) 2019, THE SURGEON REPORTED THAT THE PATIENT HAD A FAIRLY HIGH INTRAOCULAR PRESSURE (IOP) SPIKE POSTOPERATIVELY. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED TO IVANTIS ON (B)(6) 2020. PREOPERATIVELY, THE PATIENT'S IOP IN THE OPERATIVE EYE WAS 21 MMHG ON ONE IOP-LOWERING TOPICAL MEDICATION. ONE DAY POSTOPERATIVELY THE IOP INCREASED TO 32 MMHG (UNMEDICATED) AND MILD CORNEAL EDEMA WAS NOTED. ON (B)(6) 2019, THE PATIENT'S IOP DECREASED TO 21 MMHG ON 3 IOP-LOWERING MEDICATIONS. AT THIS VISIT THE CORNEAL EDEMA HAD RESOLVED AND THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IMPROVED FROM 20/40 PREOPERATIVELY TO 20/25. THE PATIENT'S STATUS WAS LISTED AS STABLE. AT THIS TIME, THE CAUSE OF THE IOP ELEVATION IS UNKNOWN. IT SHOULD BE NOTED THAT THE HYDRUS MICROSTENT WAS IMPLANTED PRIOR TO THE CATARACT PORTION OF THE PROCEDURE, WHICH WAS PERFORMED BY A DIFFERENT OPHTHALMOLOGIST (RESIDENT); A DISPERSIVE VISCOELASTIC WAS ALSO USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.