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

Model Number P-50 PL

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

A material mgr reported that after a glaucoma filtering shunt was implanted into a patient's eye, the surgeon immediately observed that there was "no flow" of fluid through the shunt.The shunt was taken out and another shunt implanted successfully.There was no harm to the pt.

Manufacturer Narrative

Eval summary: the sample was not returned yet, therefore, the condition of the product could not be verified and visual inspection cannot be performed.The device history record (dhr) for the batch was reviewed.No abnormalities were found during the dhr review and the produce was released according to release criteria.Because a sample was not returned, the root cause cannot be determined.There have been no other similar complaints reported in the lot number.(b)(4).This report was mailed to fda on: 02/13/2015.The mfr internal ref number is: (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; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4510873
• MDR Text Key: 5532121
• Report Number: 3003701944-2015-00019
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/14/2015

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: 08/30/2017
• Device Model Number: P-50 PL
• Device Catalogue Number: 47053
• Device Lot Number: 141231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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
• Patient Age: 89 YR