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 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

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.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.There have been no other complaints reported in the lot number.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that after a glaucoma filtering shunt was inserted, it was confirmed that there was "no flow" through the shunt.It was removed and another shunt was inserted, but again there was "no flow" confirmed.The second shunt was removed and the surgeon converted to a trabeculectomy only.There was no harm to the patient.Additional information was requested.There are two medical device reports associated with this event.This report is for the second shunt inserted and removed.

Manufacturer Narrative

A customer reported that no aqueous humor outflow was confirmed after implanting a shunt to a patient's eye.The shunt was replaced with a second one, but the issue recurred.The device history records (dhrs) for the batches were reviewed.No abnormalities were found during the dhr review and the products were released according to release criteria.Two products were returned for analysis and the reported complaint was not observed in either of them: the shunts' lumens were found to be open.The shunts were visually inspected: shunt#1 was found to be proper and clean and there was no evidence of a malfunction of the product.The shunt¿s lumen appeared to be clear, with no blockage.In shunt#2 mild damages were seen on the external body of the shunt and unknown material which looks like a colorless fiber was seen through the port.The shunts' lumen was found open, however unknown material, consistent with the one seen through the port was seen on the side of the lumen.Indeed, after cleaning the device light passed through both sides of the restriction unit with no obstructions.The root cause could not be conclusively determined, no manufacturing or product failures were detected.(b)(4).

Event Description

There are two follow up medical device reports associated with this event.The facility did not separately identify the two products when they were returned.Both investigations are reported on each report.

• 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: 5291540
• MDR Text Key: 33893397
• Report Number: 3003701944-2015-00705
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2018
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 144002
• Other Device ID Number: 00380650705013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2014
• 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
• Patient Age: 46 YR