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 Intraocular Pressure Increased (1937)

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.The device history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Additional information has been requested.(b)(4).

Event Description

An ophthalmologist reported that following a glaucoma filtration device (gfd) implant procedure, there was no flow of the aqueous humor even though the flap was opened.There was back flow of blood that occurred after needling and increase intraocular pressure caused by a blockage of the gfd.The gfd was explanted and a trabeculectomy was performed.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.There was no data regarding product identity received i.E.No lot or serial number were indicated for the event; therefore, the device history record (dhr) could not be reviewed.The shunts' lumen was found to be open during inner illumination.The shunt was returned within fluids therefore, the complaint cannot be negated nor confirmed.(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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5184771
• MDR Text Key: 29785401
• Report Number: 3003701944-2015-00669
• 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: 01/13/2016

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: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• 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
• Patient Age: 66 YR