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

Model Number P-50 PL

Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)

Patient Problem Intraocular Pressure Increased (1937)

Event Date 04/23/2015

Event Type  Injury  

Event Description

An ophthalmic surgeon reported following a glaucoma filtering device implant surgery the intraocular pressure was not decreased and there was almost no flow of aqueous humor.The glaucoma filtering device was removed and a trabeculectomy performed five days following the glaucoma filtering device implant.

Manufacturer Narrative

Evaluation summary: 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 sample returned on 14-may-2015, and sent for sterilization, therefore, the condition of the product was not verified yet.Because a sample was not investigated yet, the root cause cannot be determined.The root cause will be reassessed upon completing the investigation.Additional information was requested and received.(b)(4).

Manufacturer Narrative

Additional information: evaluation summary: the device was returned for evaluation.During inner illumination the shunts' lumen was found to be partially blocked.After cleaning the shunt, the lumen was opened.There is no indication of manufacturing related factors that could cause the blockage.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.The shunt had been in the patient's eye.Having said that, one may conclude, that the blockage was formed after the product had left the manufacturing plant.The root cause 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.(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 9085 0; IS 90850
• Manufacturer Contact: eddie darton, md, jd ; mail stop ab2-6; mail stop r3-48; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4798155
• MDR Text Key: 5829317
• Report Number: 3003701944-2015-00571
• 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: 07/10/2015

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: 05/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2015
• 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
• Patient Age: 74 YR