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

Model Number P-50 PL

Device Problems Excess Flow or Over-Infusion (1311); No Flow (2991)

Patient Problem Intraocular Pressure, Delayed, Uncontrolled (1936)

Event Type  Injury  

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.No sample was returned; it remains implanted, therefore, the condition of the product could not be verified.It was reported that casuality between low iop and the device was denied.Because a sample was not returned and no lot number or serial number were indicated for this complaint, the root cause cannot be determined.Additional information was requested.(b)(4).

Event Description

An ophthalmologist reported that following a glaucoma filtration device implant procedure, overfiltration of aqueous humor occurred.Six stitches were left in place.The bleb was not confirmed on postop day one.Three stitches were cut and pressure applied to the eye, but aqueous humor did not flow.A flap escalation procedure was performed but it overflowed and the iop decreased.The device remains implanted.Additional information was provided that there was no causality between the low intraocular pressure and the device.

• 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: 6070483
• MDR Text Key: 58921312
• Report Number: 3003701944-2016-00206
• 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
• Report Date: 11/01/2016

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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