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 Code Available (3191)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: 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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported following implant of a glaucoma filtration device, there was no aqueous flow observed from the device itself, but from around it in the patient's eye.The surgeon removed and replaced the device two days following the initial implant.During the replacement surgery, the surgeon enlarged the incision and removed the device.Another device was implanted and the patient is currently showing favorable progress.Additional information was requested.

Manufacturer Narrative

The sample was returned for the investigation: only the shunt was returned and found to be clogged.Therefore, the complaint is confirmed.After the cleaning the lumen was open.There is no indication for manufacturing related factors that could cause the blockage.During production, 100% final inspection is 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 factors during and after the clinical procedure.The blockage does not seem to be product related since after cleaning the device the blockage was removed.(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: 7922591
• MDR Text Key: 122297658
• Report Number: 3003701944-2018-00050
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 073097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention