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 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A surgeon reported that no aqueous humor outflow was confirmed during a glaucoma filtration device surgery.The shunt was explanted and the procedure was converted to trabeculectomy in the same procedure.

Manufacturer Narrative

Evaluation summary: customer suspected clogged shunt during implant procedure, shunt explanted, converted to trabeculectomy.This was a triple surgery involving a cataract surgery.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 released criteria.The sample was returned for investigation.The lumen was found to be blocked therefore the complaint report is confirmed.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 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: 5279042
• MDR Text Key: 33560210
• Report Number: 3003701944-2015-00703
• 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: 02/10/2016

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: 07/31/2018
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 072376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2015
• 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: 76 YR