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Adverse Event Report

BAUSCH & LOMB SURGICAL MILLENNIUM MICROSURGICAL SYSTEM OPHTHALMIC MICROSURGICAL SYSTEM   back to search results
Catalog Number CX3000
Device Problem Interference with monitoring device
Event Date 10/23/1998
Event Type  Malfunction  
Event Description

During a cataract extraction procedure, when this unit was activated, the electrocardiogram machine being used at the same time was interrupted and sounded an alarm. The system module and handpiece being used were exchanged and the procedure was able to be finished. There was no pt injury.

 
Manufacturer Narrative

Sections a through f of this medwatch was completed by the mfr.

 
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Brand NameMILLENNIUM MICROSURGICAL SYSTEM
Type of DeviceOPHTHALMIC MICROSURGICAL SYSTEM
Baseline Brand NameELITE VENTURI MILLENNIUM SYSTEM
Baseline Generic NamePHACOFRAGMENTATION UNIT
Baseline Catalogue NumberCX3000
Baseline Device FamilyMICROSURGICAL SYSTEM
Baseline Device 510(K) NumberK961310
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed08/30/1996
Manufacturer (Section F)
BAUSCH & LOMB SURGICAL
3365 tree court indl blvd.
st. louis MO 63122
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL
3365 tree court indl blvd.
st. louis MO 63122
Manufacturer (Section G)
BAUSCH & LOMB, INC.
3365 tree ct. industrial blvd.
st. louis MO 63122 6694
Manufacturer Contact
janet lacavich
3365 tree ct industrial blvd.
st. louis , MO 63122
(314) 225 -5051
Device Event Key192182
MDR Report Key197814
Event Key185890
Report Number1920664-1998-00265
Device Sequence Number1
Product CodeHQC
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/23/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCX3000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/23/1998
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer10/23/1998
Date Manufacturer Received10/23/1998
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/01/1993
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 06, 2009

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