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 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.
Additional Manufacturer Narrative
Adverse event without identified device or use problem.Known inherent risk of device.Fda report delayed due to initial incorrect assessment of this event as not reportable.(b)(4).(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, otago 9016 ; NZ 9016
• Manufacturer (Section G): MOLTENO OPHTHALMIC LTD.; 152 fredrick street; dunedin, otago 9016 ; NZ 9016
• Manufacturer Contact: janine hunter ; 152 fredrick street; dunedin, 9016 ; NZ 9016
• MDR Report Key: 19915633
• Report Number: 3001227772-2024-00001
• Device Sequence Number: 20644247
• Product Code: KYF
• UDI-Device Identifier: 09419196000212
• UDI-Public: 09419196000212
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K062252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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: 364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 120 KG