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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD / HUNTINGTON MONARCH III IOL DELIVERY SYSTEM CARTRIDGE - D LENS GUIDE

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ALCON RESEARCH, LTD / HUNTINGTON MONARCH III IOL DELIVERY SYSTEM CARTRIDGE - D LENS GUIDE Back to Search Results
Catalog Number 8065977763
Device Problems Adverse Event Without Identified Device or Use Problem; Injection System
Event Date 10/21/2014
Event Type  Injury  
Event Description

A surgeon reported that following intraocular lens (iol) implant surgery, a pt experienced endophthalmitis. The pt presented to the office with "black spots and cloudy vision", visual acuity was 20/50+, intraocular pressure was 18mmhg and 3+ cells with no hypopyon. The next day the pt returned to the office with hand motion vision and hypopyon. The pt was referred to a retinal specialist for cultures which grew out staphylococcus epidermidis. It was noted that during the first week of his post-operative care the pt was out cutting grass and had gotten some in his eye, along with some saw dust. Additional information was received from the surgeon, who reported that the infection has resolved. The pt may need a vitrectomy for derris and macular pucker and received intravitreal injections of antibiotics from a different physician.

 
Manufacturer Narrative

Complaint history and cartridge product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. Additional information was requested by phone and mail. A completed questionnaire was received. (b)(4).

 
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Brand NameMONARCH III IOL DELIVERY SYSTEM CARTRIDGE - D
Type of DeviceLENS GUIDE
Manufacturer (Section D)
ALCON RESEARCH, LTD / HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LTD/HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
janet moran
6201 south freeway, r3-48
fort worth , TX 76134
8176152742
MDR Report Key4364335
Report Number1119421-2014-01048
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 11/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8065977763
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/05/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/22/2014 Patient Sequence Number: 1
Treatment
(B)(4)
VISCOAT
ILEVRO
DUREZOL
TOBRAMYCIN
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