FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

ALCON LABORATORIES, INC./HUNTINGTON MONARCH IOL DELIVERY SYSTEM - CARTRIDGE LENS GUIDE   back to search results
Catalog Number 8065977758
Device Problem Abnormal
Event Type  Malfunction  
Event Description

A surgeon reported that an intraocular lens (iol) became stuck in the cartridge of the iol delivery system. It is not known whether there was pt impact/injury associated with this event. Add'l info has been requested.

 
Manufacturer Narrative

Eval summary: the complaint device associated with this report has not been received for eval. However, the associated intraocular lens was returned and verified to have haptic damage due to handling of the lens during surgery. No conclusions can be drawn.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameMONARCH IOL DELIVERY SYSTEM - CARTRIDGE
Type of DeviceLENS GUIDE
Baseline Brand NameMONARCH II IOL DELIVERY SYSTEM/CARTRIDGE
Baseline Generic NameLENS GUIDE, INTRAOCULAR
Baseline Catalogue Number8065977758
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 Key309913
MDR Report Key320386
Event Key301319
Report Number1119421-2001-00281
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 02/07/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/09/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065977758
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location AMBULATORY SURGICAL Facility
Date Manufacturer Received02/07/2001
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 December 31, 2008

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH