MAUDE Adverse Event Report: MOLTENO OPHTHALMIC LTD. MOLTENO3; GLAUCOMA DRAINAGE DEVICE

Model Number	SS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Vision (2139); Choroidal Hemorrhage (4810)
Date of Event	04/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: MOLTENO3
• Common Device Name: GLAUCOMA DRAINAGE DEVICE
• Manufacturer (Section D): MOLTENO OPHTHALMIC LTD.; 152 fredrick street; dunedin, 9016 ; NZ 9016
• MDR Report Key: 19915612
• Report Number: 3005641545-2024-00025
• Device Sequence Number: 20644134
• Product Code: KYF
• UDI-Device Identifier: 09419196000212
• UDI-Public: 09419196000212
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2024
• Report Date (Section F): 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SS
• Device Catalogue Number: SS185
• Device Lot Number: SS2022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 120 KG