MAUDE Adverse Event Report: FCI OPTHALMICS, INC. SELF-THREADING MONOKA; PLUG, PUNCTUM

Model Number S1.1810U

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2018

Event Type  malfunction  

Event Description

Patient was in surgery for a tear duct probe of the right eye.Physician inserted the ritleng tube into the right eye and upon positioning it, the tube broke in half.Physician removed the tube and proceeded to put in new tube.

• Brand Name: SELF-THREADING MONOKA
• Type of Device: PLUG, PUNCTUM
• Manufacturer (Section D): FCI OPTHALMICS, INC.; clinical research consultants, inc.; 3308 jefferson ave; cincinnati OH 45220
• MDR Report Key: 7326585
• MDR Text Key: 101977062
• Report Number: 7326585
• Device Sequence Number: 1
• Product Code: LZU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/01/2022
• Device Model Number: S1.1810U
• Device Catalogue Number: S1.1810U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2018
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 YR