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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EAGLE VISION, INC. GELLANSERT TEMPORARY PUNCTUM PLUG
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EAGLE VISION, INC. GELLANSERT TEMPORARY PUNCTUM PLUG Back to Search Results
Catalog Number 0040
Device Problem Insufficient Information (3190)
Patient Problem Inflammation (1932)
Event Type  Injury  
Event Description
Physician reported that gellansert temporary punctum plugs were used on a prk patient post surgery.The plugs were placed in the patient to increase the retention of ocular medication.The patient has had persistent canaliculitis od.Patient has had irrigation of the canaliculus twice, but without full resolution of the symptoms.
 
Manufacturer Narrative
It was reported that the forceps used for inserting the gellansert plugs were cleaned with alcohol wipes.This is the 2nd of 3 reports from the same reporter on the product.
 
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Brand Name
GELLANSERT TEMPORARY PUNCTUM PLUG
Type of Device
PUNCTUM PLUG
Manufacturer (Section D)
EAGLE VISION, INC.
memphis TN
Manufacturer Contact
bill graham
8500 wolf lake dr.
suite 110
memphis, TN 38133
9013807000
MDR Report Key3788310
MDR Text Key22137159
Report Number1034718-2014-00002
Device Sequence Number1
Product Code LZU
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K053333
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 04/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2014
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
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