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 Intraocular Pressure Increased (1937)

Event Date 03/10/2015

Event Type  Injury  

Event Description

A doctor of ophthalmology reported that approximately one year following a glaucoma filtration device implant procedure, the patient's intraocular pressure (iop) had increased.No flow was confirmed.The doctor suspected the device to be clogged and performed yag.The iop still had not decreased.Suture lysis was performed twice.Needling was also performed.The shunt was explanted and a trabeculectomy was performed.Additional information was received from the surgeon stating the device touched to the iris approximately one month postoperatively.

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.Results from the product history record review indicated the product met release criteria.There have been no other similar complaints reported in the lot number.Additional information was requested and received.Zip code is not indicated at this time.(b)(4).

Manufacturer Narrative

Additional information: during inner illumination the devices' lumen was found to be blocked.After cleaning the device, it was still blocked.After slicing the device, two lumen openings, on both sides of the restriction unit were seen, unknown material was found in one of the openings.Analysis of the unknown material under sem indicated that the material is an organic substance.The organic substance probably originated from the patient's eye, as the shunt was implanted for about a year.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 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 lumen openings were seen on both sides of the restriction unit 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 9085 0; IS 90850
• Manufacturer Contact: janet moran ; 6201 south freeway; mail stop r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4702689
• MDR Text Key: 20459818
• Report Number: 3003701944-2015-00539
• 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: 06/02/2015

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: 03/31/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 04/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2015
• 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: 59 YR