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 Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2019

Event Type  Injury  

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.Since the sample has not been received, the complaint could not be confirmed, and the root cause could not be determined.There are no other complaints in the lot.Additional information was requested.(b)(4).

Event Description

During a glaucoma filtering shunt implant procedure, once the shunt was put into place in the eye, fluid did not flow through it.A clog was suspected, so the shunt was immediately removed and alternate glaucoma surgery was performed.Additional information was requested.

Manufacturer Narrative

The sample has been received and investigated: the sample returned in an open secondary package and included: the delivery system (ds) in a cradle, the shunt in a separate plastic bag, and ifu.-the ds wire was fully pressed.The ds was pulled back and didn¿t protrude from the cannula opening.The shunt was covered with dirt and residues.The shunt lumen was blocked.After the cleaning the shunt lumen was open.After the cleaning the shunt was investigated: it had damages over its body surface.All products pass 100% final inspection prior to approval.If a defect would be noticed, the product would have been rejected.Having said that, one may conclude that the blockage was formed after the product left the manufacturing plant.The root cause is inconclusive - unable to verify, since the blockage could have been caused by many different reasons during the clinical procedure.However, the complaint on blockage is confirmed.The blockage does not seem to be product related since after cleaning the device - the blockage was removed.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: 8310259
• MDR Text Key: 135177921
• Report Number: 3003701944-2019-00005
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: P-50 PL
• Device Catalogue Number: 24053
• Device Lot Number: 073085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention