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

Model Number P-50 PL

Device Problem No Flow (2991)

Patient Problems Intraocular Pressure, Delayed, Uncontrolled (1936); No Code Available (3191)

Event Date 09/22/2014

Event Type  Injury  

Event Description

A surgeon reported approximately 15 months following an implantation of a glaucoma filtration device, the shunt became clogged.The intraocular eye pressure (iop) increased; no flow of the aqueous humor was noted while an eye message was being performed.The shunt was removed.Additional info is not expected.

Manufacturer Narrative

Evaluation summary: the product was returned fo 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.Results from the product history review indicated the product met release criteria.There have been no similar complaints reported for the same lot number.(b)(4).

• Brand Name: EX-PRESS MINI GLAUCOME 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; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4193224
• MDR Text Key: 5150827
• Report Number: 3003701944-2014-00198
• 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: 09/24/2014

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 Expiration Date: 12/30/2015
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053 JAPAN
• Device Lot Number: 122924
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• 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): Required Intervention