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

Model Number P-50 PL

Device Problem No Flow (2991)

Patient Problem No Information (3190)

Event Date 12/16/2014

Event Type  Injury  

Event Description

A surgeon reported that approximately nine months after a glaucoma filtering shunt was implanted, it was confirmed that ther was no flow of fluid through the shunt.The shunt was explanted.Additional information was requested.

Manufacturer Narrative

Evaluation summary: the product was returned for 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.No data regarding product identity was received i.E no lot or serial number indicated for the event; therefore, the device history record (dhr) could not be reviewed.Additional information was requested.(b)(4).

• Brand Name: EX-PRESS MINI GLAUCOMA SHUT
• 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: 4417907
• MDR Text Key: 5421043
• Report Number: 3003701944-2015-00009
• 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: 12/16/2014

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 Model Number: P-50 PL
• Device Catalogue Number: 60053 JAPAN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: No
• 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