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 Code Available (3191)

Event Date 01/06/2016

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.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 sample was returned, therefore, the condition of the product could not be verified and visual inspection cannot be performed.The root cause could not be conclusively determined and does not seem to be device related.There have been no other complaints reported in the lot number.Additional information was requested.(b)(6).(b)(4).

Event Description

A surgeon reported that approximately two years after a glaucoma filtering shunt was implanted, the intraocular pressure began to increase and was treated with eye drop medication.The filtering bleb was collapsed, so the patient was taken back to surgery for a bleb revision.During the revision, the surgeon was able to determine that there was no fluid passing through the shunt.At that time, the shunt was explanted.Additional information was requested.

Manufacturer Narrative

Only shunt was received for investigation.During initial inner illumination test, partial blockage of the lumen was found.After cleaning the device the blockage was removed.Light passed through both sides of the restriction unit.Therefore, there is no indication for a manufacturing related factors that could cause the blockage.During production, 100% final inspection is being performed on the entire batch, including visual inspection and inner illumination.If a blockage would be noticed, the product would have been rejected immediately.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 and after the clinical procedure.The blockage does not seem to be product related since after cleaning the device the blockage was removed.Therefore, there is no evidence for an inherent defect that might have caused the event.(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
• Manufacturer (Section G): OPTONOL LTD.; kiryat hatikshoret; communication center; neve-ilan 90850 ; IS 90850
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5450872
• MDR Text Key: 38665849
• Report Number: 3003701944-2016-00044
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/30/2015
• Device Model Number: P-50 PL
• Device Catalogue Number: 24053
• Device Lot Number: 122931
• Other Device ID Number: 00380650704962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR