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

Model Number	SL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A molteno3 sl-245 was implanted then explanted.Customer relayed that the tube was not ligating.The surgeon explanted the device and replaced it with a different brand glaucoma drainage device with no issue.

• Brand Name: MOLTENO3
• Common Device Name: GLAUCOMA DRAINAGE DEVICE
• Manufacturer (Section D): MOLTENO OPHTHALMIC LTD.; 152 fredrick street; dunedin, 9016 ; NZ 9016
• Manufacturer (Section G): MOLTENO OPHTHALMIC LTD.; 152 fredrick street; dunedin, 9016 ; NZ 9016
• Manufacturer Contact: janine hunter ; 152 fredrick street; dunedin, 9016 ; NZ 9016
• MDR Report Key: 25480630
• Report Number: 3001227772-2026-00001
• Device Sequence Number: 9966070
• Product Code: KYF
• UDI-Device Identifier: 09419196000229
• UDI-Public: 09419196000229
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: SL
• Device Catalogue Number: SL245
• Device Lot Number: SL2024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male