MAUDE Adverse Event Report: EAGLE VISION, INC. SUPEREAGLE LARGE PUNCTUM PLUG

Catalog Number 3132

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Sensation in Eye (1869); Red Eye(s) (2038)

Event Date 10/04/2014

Event Type  Injury  

Event Description

Pt developed granulation tissue around the plug that caused the extrusion of the plug.The plug then rubbed the cornea and conjunctiva causing red eye and foreign body sensation.The physician excised the granulation tissue and plug.Pt received no add'l treatment.

Manufacturer Narrative

During a discussion with the physician it was determined that he was not gauging the puncta prior to selecting and inserting punctum plugs.The ifu states to gauge and puncta to determine the proper size plug.A gauge was sent to the physician.

• Brand Name: SUPEREAGLE LARGE PUNCTUM PLUG
• Type of Device: PUNCTUM PLUG
• Manufacturer (Section D): EAGLE VISION, INC.; memphis TN
• Manufacturer Contact: bill graham, qa/ra mgr. ; 8500 wolf lake dr.; suite 110; memphis, TN 38133 ; 9013807050
• MDR Report Key: 4273037
• MDR Text Key: 16001236
• Report Number: 1034718-2014-00006
• Device Sequence Number: 1
• Product Code: LZU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3132
• Device Lot Number: 77986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 52