MAUDE Adverse Event Report: OPTONOL LTD. EX-PRESS GLAUCOMA FILTRATION DEVICE; IMPLANT, EYE VALVE

Model Number	P-50 PL
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during glaucoma shunt implant procedure, inserter had issue and shunt had to be removed.Additional information received stating physician inserted the shunt into the patient's left eye but the shunt was not supported and the tip was embedded in the iris.Shunt remained in the eye, and physician was not able to remove and reinserted the shunt.Shunt removal and replacement was planned.Additional information received stating glaucoma shunt was explanted 12 days after the initial implant procedure.
Additional Manufacturer Narrative
Corrected information was provided in d.4.Additional information was provided in h.3., h.6.And h.11.A sample was not received at the investigation site for evaluation for the report of shunt would not release, shunt implanted incorrectly, and explant; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A sample was not received at the investigation site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: EX-PRESS GLAUCOMA FILTRATION DEVICE
• Common Device Name: IMPLANT, EYE VALVE
• Manufacturer (Section D): OPTONOL LTD.; kiryat hatikshoret; communication center; neve-ilan 90850 ; IS 90850
• Manufacturer (Section G): OPTONOL LTD.; kiryat hatikshoret; communication center; neve-ilan 90850 ; IS 90850
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19793741
• Report Number: 3003701944-2024-00030
• Device Sequence Number: 12541155
• Product Code: KYF
• UDI-Device Identifier: 00380650704931
• UDI-Public: (01)00380650704931(17)270228(11)230914(10)16033A(21)NA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K012852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P-50 PL
• Device Catalogue Number: 47053
• Device Lot Number: 16033A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 12/05/2024
• Date Device Manufactured: 09/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DIFLUPREDNATE; MAXITROL OINTMENT; MOXIFLOXACIN
• Patient Age: 79 YR
• Patient Sex: Female