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Adverse Event Report

BAUSCH & LOMB SURGICAL MILLENNIUM MICROSURGICAL SYSTEM OPHTHALMIC MICROSURGICAL UNIT   back to search results
Catalog Number CX3000
Device Problem Vacuum, loss of
Event Date 01/03/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

This unit lost vacuum during a phacoemulsification procedure. Two backup units were brought in but both failed to boot up properly. Because of the delay the doctor performed an extracap procedure and the pt experienced a delay in recovery. No add'l problems were reported.

 
Manufacturer Narrative

During testing, the module would not prime due to a failure with the transducer box. The stepper motor connector and transducer box lemo connector were unseated from the mating connector, but still making contact. The brass bushings on the front mounting plate were not recessed and calibration solenoid plunger was bent.

 
Search Alerts/Recalls

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Brand NameMILLENNIUM MICROSURGICAL SYSTEM
Type of DeviceOPHTHALMIC MICROSURGICAL UNIT
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 indust. blvd.
st. louis MO 63122
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL
3365 tree court indust. blvd.
st. louis MO 63122
Manufacturer Contact
juli moore
3365 treecourt industrial blvd
st. louis , MO 63122
(636) 226 -3220
Device Event Key303914
MDR Report Key314247
Event Key295423
Report Number1920664-2001-00007
Device Sequence Number1
Product CodeHQC
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/03/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberCX3000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/05/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2000
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 December 31, 2008

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