Description of Event or Problem · 0
ON 14 JUL 2023, NOVA EYE, INC. BECAME AWARE OF A REPORTED ADVERSE EVENT FOR THE MOLTENO3 GLAUCOMA DRAINAGE DEVICE, SS-185 WHICH NOVA EYE, INC. IMPORTS AND DISTRIBUTES IN USA. DATE OF IMPLANT WAS (B)(6) 2023. PATIENT DETAILS OBTAINED INDICATE A POST SUPRACHOROIDAL HEMORRHAGE OCCURRED ON (B)(6) 2023 IN THE PATIENTS RIGHT EYE DUE TO THE OPENING OF THE GLAUCOMA TUBE AND LIGATION SUTURE. CONSEQUENCE FOR THE PATIENT WAS LOSS OF VISION. THE OUTCOME ANTICIPATED BY THE SURGEON WAS LONG-TERM POOR VISION. THE INITIAL REPORT RECEIVED BY NOVA EYE INDICATED THAT TWO PATIENTS HAD EXPERIENCED HYPOTONY AND LOSS OF VISION AS A RESULT OF A MOLTENO GDD IMPLANT. HOWEVER, DURING FOLLOW UP WITH THE SURGEON, ONLY ONE PATIENT DETAILS WERE PROVIDED. NO INDICATION OF HYPOTONY WAS INCLUDED IN THESE DETAILS. THE PATIENTS PRE-OP PRESSURE WAS 30MMHG IN RIGHT EYE. POST-OP PRESSURE RANGED FROM 38 TO 47MMHG ON MAXIMUM TOPICAL MEDICATION. FDA REPORT DELAYED DUE TO INITIAL INCORRECT ASSESSMENT OF THIS EVENT AS NOT REPORTABLE. NOVA EYE, INC. (IMPORTER) AND MOLTENO OPHTHALMIC LTD, (MANUFACTURER) ARE SUBSIDIARIES OF NOVA EYE MEDICAL LTD.