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 Type  malfunction  

Manufacturer Narrative

The device was received by a company representative and is in transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The product has not been returned to manufacturing.There are no other complaints in the lot.(b)(4).

Event Description

A surgeon reported that during a glaucoma filter shunt (gfs) procedure, there was no flow of aqueous humor through the shunt.The surgeon removed the shunt and did a trabeculectomy only without the filtering shunt.Additional information was requested.

Manufacturer Narrative

The sample was received in a plastic bag with medical band.On the band was placed a shunt.The sample was without scratches or damages.Some residues were observed on the sample.The lumen was clogged.After a cleaning, the lumen was open.No other complaints for the lot.All products pass 100% final inspection prior to approval.If a defect would be noticed, the product would have been rejected.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.Additional information was provided in d.10., h.3., h.6.And h.10.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: 10079281
• MDR Text Key: 192146681
• Report Number: 3003701944-2020-00023
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2020
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1