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

Model Number	P-50 PL
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported that during a glaucoma filtration device implantation, the device did not eject.Additional information was received nd stated that, there was no patient harm and the procedure was completed on the same day.
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).
Additional Manufacturer Narrative
Additional information provided in d.4., d.9., h.3., h.6., and h.10.The sample was received at the manufacturing site and investigated as follows: - the sample was returned in an open secondary packaging.Sample front found torn.- the sample included only a cradle and the eds (express delivery system)- which was found non fixed to cradle in an oriented state.- ifu, pouch, labels and patient card were not received as of original packaging configuration.In addition, shunt was not included with received package.- the eds wire found triggered.- the eds wire did not protrude from cannula opening.A root cause for the customers reported event could not be determined because the returned product met manufacturer¿s specifications.No supporting data was presented, obtained or identified while investigation concluding product contributing factors are related to the event.Shunt was detached from eds (since it was not included in the received sample) and the eds was operated and performed its functionality releasing the shunt product malfunction or cause could not be determined with relation to the event.Relationship of the product to the event is unclear.Reported event can not be conformed.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: 16059166
• Report Number: 3003701944-2022-00020
• Device Sequence Number: 5306958
• Product Code: KYF
• UDI-Device Identifier: 00380650704931
• UDI-Public: 00380650704931
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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 Expiration Date: 05/31/2025
• Device Model Number: P-50 PL
• Device Catalogue Number: 47053
• Device Lot Number: 1427WL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• 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
• Patient Sex: Male