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

Model Number P-50 PL

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

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 release criteria.No other complaints for this lot.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that a glaucoma filtering shunt did not flow.There was no reported patient impact.Additional information was requested.

Manufacturer Narrative

(b)(4).

Event Description

In a follow up, the reporter explained that the device was inserted into the eye and did not shunt the fluid as expected so it was removed and the procedure was completed as a trabeculectomy procedure only.There was no patient harm.

Manufacturer Narrative

The sample was returned for the investigation: it included delivery system (ds) with opened primary packaging (pouch).Both the shunt and ds were returned for investigation inside the pouch.The cradle was attached.The ds wire was pressed down and slightly protruded from the cannula opening.The shunt body was with dirt residues and scratches.The disc is bent.The lumen was partially clogged.After cleaning the shunt inner lumen was found to be open, there was no indication of any manufacturing relating factors that could cause the reported event.The root cause is inconclusive - unable to verify since the blockage could have been caused by many different reasons during and after the clinical procedure.The blockage does not seem to be product related since after the shunt cleaning the blockage was removed.However, the complaint of "shunt not draining properly during implant procedure" may be confirmed.The manufacturer internal reference number is: (b)(4).

• Brand Name: EX-PRESS GLAUCOMA FILTRATION DEVICE
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): OPTONOL LTD.; kiryat hatikshoret; communication center; neve-ilan 90850 ; IS 90850
• MDR Report Key: 8038871
• MDR Text Key: 128199130
• Report Number: 3003701944-2018-00054
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: P-50 PL
• Device Catalogue Number: 40753
• Device Lot Number: 073049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1