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

Model Number	P-50 PL
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
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 after the glaucoma filtration device implantation, elevated intraocular pressure (iop) of 40 mmhg was noted on post-operative day one.The shunt was observed to be in position in the anterior chamber on gonioscopy.Ocular massage and laser suture lysis were attempted; however, due to the failure of the shunt, a decision was made to proceed with surgical revision.The existing shunt was removed and replaced with another device.The patient's issue was subsequently resolved.
Additional Manufacturer Narrative
Additional information was added in h.3., h.6.And h.11.A sample was not received at the investigation site for evaluation for the report of intraocular pressure (iop) elevated, ultimate failure of glaucoma shunt, and removal; therefore, the condition of the product could not be verified.Since the sample has not arrived at manufacturing site the complaint file will be closed as a no sample returned.If and when the sample arrives the complaint file will be reopened for evaluation of the sample.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.The investigation conducted a non-conformance review of the reported lot number.No deviations, were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information received, the investigation was unable to identify the root cause or origin of the reported event.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.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: 22532696
• Report Number: 3003701944-2025-00006
• Device Sequence Number: 7473448
• Product Code: KYF
• UDI-Device Identifier: 00380650704931
• UDI-Public: (01)00380650704931(17)270331(11)231019(10)160340
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K012852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: P-50 PL
• Device Catalogue Number: 47053
• Device Lot Number: 160340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/26/2025
• Date Device Manufactured: 10/19/2023
• 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: ATROPINE; KETOROLAC; OFLOXACIN; PREDNISOLONE ACETATE; RESTARTED COMBIGAN BID; STARTED ACETAZOLAMIDE PO BID
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American