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 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the sample was returned but not investigated yet, therefore, the condition of the product was not verified.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 the manufacturer's release criteria.Because a sample was not returned, the root cause cannot be determined.The root cause will be reassessed upon completing the investigation.Additional information has been requested.(b)(4).

Event Description

A surgeon reported no flow of the aqueous humor during a glaucoma filtering device implant procedure.The device was removed and replaced during the initial procedure.

Manufacturer Narrative

Customer reported that no flow was confirmed after the shunt was implanted.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 manufacturer's release criteria.The following findings were obtained during investigation of the returned product: 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5870209
• MDR Text Key: 52747290
• Report Number: 3003701944-2016-00168
• 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: 09/18/2016

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
• Other Device ID Number: 00380650705013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/18/2016
• 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