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 06/09/2014

Event Type  malfunction  

Event Description

A surgical technician reported that during a glaucoma filtration device (gfd) implant procedure, the surgeon did not observe any flow, therefore, he removed it from the eye and completed the procedure as a trabeculectomy.The patient had a good outcome.

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis, 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 product was released according to release criteria.The root cause cannot be determined.There have been no other complaints reported in the lot number.Attempts have been made to obtain additional by phone, fax, and mail.A completed questionnaire was received.(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: 3998593
• MDR Text Key: 4708627
• Report Number: 3003701944-2014-00102
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2014

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: 12/30/2016
• Device Model Number: P-50 PL
• Device Lot Number: 133137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2014
• Initial Date FDA Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 61 YR