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Adverse Event Report

ALCON LABORATORIES., INC./HUNTINGTON MONARCH IOL DELIVERY SYSTEM - CARTRIDGE LENS GUIDE   back to search results
Device Problem Lens, damaged by cartridge
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A nurse reports that an intraocular lens (iol) was damaged in the cartridge of the iol delivery system. The damage to the lens was noted after the iol was inserted. The incision was enlarged to facilitate removal of the lens. Add'l info has been requested.

 
Manufacturer Narrative

H. 3. , 6. : the complaint device associated with this report has not been received for evaluation. However, the associated intraocular lens was returned and verified to have haptic and optic damage due to handling. No conclusions can be drawn. The product history records could not be reviewed because the facility did not provide a product lot number for the reported complaints.

 
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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 Key375477
MDR Report Key386443
Event Key364901
Report Number1119421-2002-00122
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 03/07/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2002
Is This An Adverse Event Report? Yes
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
Date Manufacturer Received03/07/2002
Was Device Evaluated By Manufacturer? Yes
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 December 31, 2008

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