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 Consequences Or Impact To Patient (2199)

Event Date 07/19/2016

Event Type  Injury  

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.(b)(4).

Event Description

A customer reported following a glaucoma filtration device implant procedure, there was no flow of aqueous humor from the device.The device was explanted because the customer thinks the device is clogged.A trabeculectomy was performed.Additional information was requested.

Manufacturer Narrative

A customer reported that no aqueous humor outflow was confirmed 2 months after implanting a shunt to a patient's eye.The shunt was explanted and trabeculectomy was performed.No data regarding product identity was received i.E.No lot or serial number were indicated for the event; therefore, the device history record (dhr) could not be reviewed.The product was returned for analysis and the reported complaint was confirmed.In addition an unknown material seen on the shunt back plate.After slicing the shunt, the lumen was seen to be open, 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 had left the manufacturing plant.The root cause is external - related to patient condition / non-product factors, however, 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 two lumens, on either side of the restriction unit were found and no welding penetrations were found.Therefore, there is no evidence for an inherent defect that might have caused the event, and the root cause is seem to be external - related to patient condition / non-product factors.(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: 5961625
• MDR Text Key: 55108887
• Report Number: 3003701944-2016-00183
• 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: 11/29/2016

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 Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention