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Adverse Event Report

ALCON LABORATORIES, INC./HUNTINGTON MONARCH IOL DELIVERY SYSTEM - CARTRIDGE LENS GUIDE   back to search results
Device Problem Abnormal
Event Type  Malfunction  
Event Description

A user facility reported that an intraocular lens (iol) became stuck in the cartridge of an iol delivery system. Pt impact is unknown. Add'l info has been requested.

 
Manufacturer Narrative

H. 3. , 6. : the complaint device has not been returned for eval. An empty intraocular lens carton was returned.

 
Search Alerts/Recalls

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Brand NameMONARCH IOL DELIVERY SYSTEM - CARTRIDGE
Type of DeviceLENS GUIDE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALCON LABORATORIES, INC./HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section D)
ALCON LABORATORIES, INC./HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
sherri lakota
6201 south freeway
fort worth , TX 76134-2099
(817) 568 -6179
Device Event Key313680
MDR Report Key324214
Event Key305008
Report Number1119421-2001-00426
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation UNKNOWN
Remedial Action Other
Type of Report Initial
Report Date 02/26/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Manufacturer Received02/26/2001
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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