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

Lot Number 132009

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

A surgeon reported three filtration devices had to be removed during surgery because they were not draining.A fourth device was implanted on the pt during the same surgery.Add'l info was requested and rec'd.This is one of three medical device reports being filed for this event.This report is for the first device.

Manufacturer Narrative

The device was rec'd by a company rep and is in transit to the mfg 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 add'l reportable info becomes available.Add'l info was requested and rec'd.(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: 3810792
• MDR Text Key: 4383777
• Report Number: 3003701944-2014-00031
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 02/20/2014

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: 10/30/2016
• Device Lot Number: 132009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• 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