MAUDE Adverse Event Report: ALLERGAN (IRVINE) XEN 45 GTS; IMPLANT, EYE VALVE

Catalog Number 5507-001

Device Problems Defective Component (2292); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.Clarification to serial and lot#: serial number (b)(4), lot number 62263.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported needle was bent with the connection between the needle and the injector was open and there was movement in the needle during the xen®45 gts implant surgery of the right eye.Surgery was completed with another xen®45 gts.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Healthcare professional reported needle was bent with the connection between the needle and the injector was open and there was movement in the needle during the xen®45 gts implant surgery of the right eye.Surgery was completed with another xen®45 gts.

• Brand Name: XEN 45 GTS
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• MDR Report Key: 9158152
• MDR Text Key: 167434126
• Report Number: 3011299751-2019-00255
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• PMA/PMN Number: K161457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 5507-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR