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

Model Number P-50 PL

Device Problems Complete Blockage (1094); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2015

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the sample was not returned form sterilization yet, therefore, the condition of the product was not verified and visual inspection was not performed.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 approved release criteria.Because the sample was not inspected yet, the root cause cannot be determined.The root cause will be reassessed upon completing the investigation.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that during a glaucoma filtration device implant procedure, the device was clogged.There was no flow of aqueous humor confirmed.The device was exchanged with a backup.Additional information was requested.

Manufacturer Narrative

Evaluation summary: during inner illumination the devices' lumen was found to be blocked.After cleaning the device, the lumen remained blocked.After slicing the device lumen, openings were seen on both sides of the restriction unit and no welding penetration were found.Therefore, there is no indication of manufacturing related factors that could cause the blockage.No abnormalities were found during the batch review and the product was released according to approved release criteria.During production, 100% final inspection is being performed on the entire batch, including inner illumination.If such a defect had been noticed during the inspection, the product would have been rejected immediately.Having said that, one may conclude, that the blockage was formed after the product had left the manufacturing plant.The root cause is cannot 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 the restriction unit was seen to be centered and after cleaning the device no light obstructions were seen.Therefore, there is no evidence for an inherent defect that might have caused the event, and the root cause cannot be conclusively determined.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
• 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: 4945875
• MDR Text Key: 23025089
• Report Number: 3003701944-2015-00610
• 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
• Report Date: 09/16/2015

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: 072370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2015
• 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