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

Model Number	P-50 PL
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.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 other health care professional reported during the intraocular lens implantation when the shunt was inserted into the space it came out.The device was removed and replaced with new one.There was no harm to the patient.Additional information has been requested.
Additional Manufacturer Narrative
Complaint history review: no other complaints: complaint lot search reviewed, there are no other complaints for the reported lot.A review of the reported lot device history record was performed.The lot met all manufacturing release specifications.The lot was processed and released according to the product¿s acceptable criteria.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be evaluated.No sample received: a root cause for the customers reported event could not be determined as no sample was received at investigation site.No supporting data was presented, obtained or identified while investigation concluding product contributing factors are related to the event.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: 16654615
• Report Number: 3003701944-2023-00009
• Device Sequence Number: 20484790
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: 01/31/2026
• Device Model Number: P-50 PL
• Device Catalogue Number: 47053
• Device Lot Number: 14V85M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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: Unknown