Molteno3 SS-185Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09419196000212), received between Aug 6, 2024 and Aug 6, 2024 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29 AUG 2023, MOLTENO OPHTHALMIC LTD BECAME AWARE OF A REPORTED ADVERSE EVENT FOR THE MOLTENO3 GLAUCOMA DRAINAGE DEVICE, (B)(6). DATE OF IMPLANT WAS (B)(6) 2023. PATIENT DETAILS OBTAINED INDICATE A POST SUPRACHOROIDAL HEMORRHAGE OCCURRED ON (B)(6) 2023 IN THE PATIENT'S 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 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.

  Patient problems: Choroidal Hemorrhage; Loss of Vision

  MAUDE report 19915633 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Choroidal Hemorrhage; Loss of Vision

  MAUDE report 19915612 ↗