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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 Device failure
Event Date 11/10/1998
Event Type  Malfunction  
Event Description

During a posterior procedure, there was an intermittent problem with this machine: the cassette would not seat properly and there was no aspiration. Another unit was used for the procedure.

 
Manufacturer Narrative

Sections a through f of this medwatch were 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 ct. industrial blvd.
st. louis MO 63122
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL
3365 tree ct. industrial 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 Key195852
MDR Report Key201639
Event Key189422
Report Number1920664-1998-00283
Device Sequence Number1
Product CodeHQC
Report Source Manufacturer
Source Type User facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/11/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/1998
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 Date11/10/1998
Device Age4 mo
Event Location Hospital
Date Report TO Manufacturer11/11/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/1998
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 February 28, 2009

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