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

Model Number P-50 PL

Device Problems Inadequate Filtration Process (2308); Defective Device (2588)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product 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 product investigation could not identify a root cause.There have been no other similar complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during a glaucoma filtration device (gdf) procedure, the device was defective as there was no filtration.The incision was increased to remove the gfd.

Manufacturer Narrative

Evaluation summary: complaint trend review has been performed for the updated event codes: shunt not draining properly during implant procedure, p-procedure-enlarged incision and p-removal-non iol, during initial procedure.One other complaint with the same code "filtration issue" for the same lot.The root cause cannot be determined as no sampled had been returned.Therefore, the complaint cannot be confirmed.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
• MDR Report Key: 8142750
• MDR Text Key: 129649983
• Report Number: 3003701944-2018-00059
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: P-50 PL
• Device Catalogue Number: 47052
• Device Lot Number: 072746
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention