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 Code Available (3191)

Event Date 02/10/2014

Event Type  Injury  

Event Description

A surgeon reported that approximately six months after a glaucoma filtering shunt was implanted, he noted the filtering bleb to be flat.The surgeon returned to surgery with the pt and opened the flap.He observed that the shunt was not flowing.The shunt was then explanted.In a follow up, the surgeon provided surgical dates.Additional info was requested.

Manufacturer Narrative

The shunt was found to be clogged when received from sterilization.After the shunt's lumen was cleaned it was found to be open.In light of these findings, the complaint is confirmed as the shunt arrived clogged.Since the device arrived clogged and after cleaning the blockage was removed, the possibility of the blockage occurring due to a manufacturing error (i.E.Mental welding or any other manufacturing process) is negated, because otherwise it would not be removed during cleaning.During production, a 100% qc inspection is being performed on the entire batch.If such a defect would be noticed, the product would have been rejected.One may conclude that the blockage was formed after the product left the manufacturing plant.There have been no other complaints reported in the lot number.Additional info was 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; r3-46; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3738616
• MDR Text Key: 4277816
• Report Number: 3003701944-2014-00027
• 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: 02/19/2014

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: 123036
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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