MAUDE Adverse Event Report: OPTONOL, LTD EX-PRESS MINI GLAUCOMA SHUNT; AQUEOUS SHUNT

Model Number P-50 PL

Device Problems Complete Blockage (1094); No Flow (2991)

Patient Problem Intraocular Pressure Increased (1937)

Event Date 03/01/2014

Event Type  Injury  

Event Description

A surgeon reported that approximately eighteen months after a glaucoma filtering device was implanted, the pt had increased intraocular pressure.In a follow up, the surgeon reported that although the pt was prescribed medicine, performed eye massages, previously had a suture lysed, and a recent needing procedure performed, the intraocular pressure remained at an increased level.The pt was admitted into the hospital for one month.During the hospital stay, the surgeon lifted the flap over the shunt and confirmed that there was minimal flow of aqueous humor and the shunt was getting clogged.A week later, the shunt was removed and a trabeculectomy was completed.The surgeon explained that he thought a backflow of blood caused by the eye messages was associated with causing the shunt to clog.The surgeon reported that the pt is recovering.

Manufacturer Narrative

The device was received by a company rep and is in transit to the mfr site for investigation.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.(b)(4).

• Brand Name: EX-PRESS MINI GLAUCOMA SHUNT
• Type of Device: AQUEOUS SHUNT
• Manufacturer (Section D): OPTONOL, LTD; communication center; neve ilan 90850 ; IS 90850
• Manufacturer (Section G): OPTONOL, LTD; communication center; neve ilan 9085 0; IS 90850
• Manufacturer Contact: janet moran ; 6201 s freeway; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3940275
• MDR Text Key: 4579771
• Report Number: 3003701944-2014-00089
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2014

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 JAPAN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2014
• Initial Date FDA Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR