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

Model Number	P-50 PL
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/17/2021
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 customer reported the shunt found to be in an awkward position during implantation.The surgery site was opened and it was found that sclera was torn and the shunt was unstable.The shunt was removed during the same procedure and the case was converted to be a trabeculectomy.No patient injury was noted.Additional information was requested.
Additional Manufacturer Narrative
Customer reported that a shunt ¿that had a problem".No other complaints for this lot.The sample has not been received; therefore, the condition of the product could not be verified and visual inspection could not be performed.The device history record (dhr) for the batch was reviewed.No abnormalities were found during the dhr review and the product was released according to company release criteria.Since the sample has not been received, the root cause can not be determined and the complaint cannot be confirmed.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
• MDR Report Key: 12012471
• Report Number: 3003701944-2021-00018
• Device Sequence Number: 17238029
• Product Code: KYF
• UDI-Device Identifier: 00380650704931
• UDI-Public: 380650704931
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/14/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: P-50 PL
• Device Catalogue Number: 47053
• Device Lot Number: 073288
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other