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

Model Number P-50 PL

Device Problems Device Contamination with Chemical or Other Material (2944); No Flow (2991)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

A surgeon reported that during a glaucoma filtration device implant procedure, there was no flow or aqueous humor.It was suspected that the device was clogged by material adhering to the operating of the device.The material was removed from the device during the procedure.The shunt was removed during the initial procedure.Material that resembled metal pieces were found in the anterior chamber of the eye after infusing bss.The foreign material was removed from the anterior chamber during surgery.A trabeculectomy was performed after the device was removed.Additional information was requested.

Manufacturer Narrative

Evaluation summary: the sample was returned for analysis, and transferred for visual inspection.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 complaints reported in the lot number.Additional information has been requested.(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 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4053381
• MDR Text Key: 16545428
• Report Number: 3003701944-2014-00150
• 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: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2017
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053 JAPAN
• Device Lot Number: 141903
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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: BSS