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 Information (3190)

Event Date 02/09/2015

Event Type  Injury  

Event Description

A surgeon reported that after a glaucoma filtering shunt was implanted there was no flow of aqueous humor and the surgeon considered the shunt clogged.The shunt was then explanted and a trabeculectomy was completed.Additional information was requested.

Manufacturer Narrative

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.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.Additional information was requested.(b)(4).

Manufacturer Narrative

During inner illumination the shunts' lumen was found to be blocked.Therefore, the complainant statement regarding no flow is confirmed.After cleaning the shunt, light passed through one side of the restriction unit.Date of implant is unknown, however the shunt had been in contact with the patient eye.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 could not be conclusively determined, since the blockage could have been caused by many different reasons during and after the clinical procedure.There is no indication of manufacturing related factors that could cause the blockage.(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: 4596154
• MDR Text Key: 5484113
• Report Number: 3003701944-2015-00507
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2015

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: 03/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2015
• Initial Date FDA Received: 03/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2015
• 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
• Treatment: ASKU
• Patient Outcome(s): Other; Required Intervention