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Adverse Event Report

ALCON LABORATORIES, INC./HUNTINGTON MONARCH IOL DELIVERY SYSTEM - CARTRIDGE LENS GUIDE   back to search results
Catalog Number 8065977725
Device Problem Abnormal
Event Type  Malfunction  
Manufacturer Narrative

Eval summary: the complaint device associated with this report was returned for eval, but no defects were noted. The associated intraocular lens was also returned and verified to have haptic and optic damage due to handling of the lens during surgery. One haptic was pulled out of the optic and the optic was torn/split/cracked in the haptic insertion area of the removed haptic. The observations documented in this eval reasonably suggest that the lens damage occurred during manipulation of the lens during surgery.

 
Event Description

A user facility reports that an intraocular lens (iol) became stuck in the cartridge of the iol delivery system. There was no pt impact/injury associated with this event.

 
Manufacturer Narrative

H. 3. ,6. : the complaint device associated with this report has not been received for eval.

 
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Brand NameMONARCH IOL DELIVERY SYSTEM - CARTRIDGE
Type of DeviceLENS GUIDE
Baseline Brand NameACRYPAK FOLDER
Baseline Generic NameLENS GUIDE, INTRAOCULAR
Baseline Catalogue Number8065977725
Baseline Device FamilyLENS GUIDE, INTRAOCULAR
Baseline Device 510(K) NumberK981571
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed07/09/1998
Manufacturer (Section F)
ALCON LABORATORIES, INC./HUNTINGTON
6065 kyle ln
huntington WV 25702
Manufacturer (Section D)
ALCON LABORATORIES, INC./HUNTINGTON
6065 kyle ln
huntington WV 25702
Manufacturer Contact
sherri lakota
6201 south freeway
fort worth , TX 76134-2099
(817) 568 -6179
Device Event Key307749
MDR Report Key318226
Event Key299199
Report Number1119421-2001-00219
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation UNKNOWN
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/26/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065977725
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/30/2001
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Manufacturer Received01/26/2001
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 February 28, 2009

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