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

Model Number P-50 PL

Device Problem Occlusion Within Device (1423)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: 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.(b)(4).

Event Description

A surgeon reported that following a glaucoma filtration device (gfd) implant procedure, the patient's intraocular pressure did not decrease.He suspected the device was clogged and removed it in a secondary procedure.There was no patient harm.Additional information was requested.

Manufacturer Narrative

Additional information provided: product evaluation: no data regarding product identity was received i.E.No lot or serial number were indicated for the event; therefore, the device history record (dhr) could not be reviewed.The device was returned for investigation: the lumen was found to be clogged.Therefore, the complaint can be considered confirmed.After the cleaning the lumen was open.All products pass 100% final inspection at the manufacturer prior to approval.If a defect would be noticed, the product would have been rejected and segregated immediately.Since the blockage was removed after cleaning the device, there is no indication for a manufacturing related factors that could cause the blockage and it seems that the blockage was formed after the product left the manufacturing plant.The root cause could not be conclusively determined since the blockage could have been caused by many different reasons after the clinical procedure.The blockage does not seem to be product related since after the shunt cleaning 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: 7172861
• MDR Text Key: 96663083
• Report Number: 3003701944-2018-00008
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• 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
• Other Device ID Number: 00380650705013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention