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Adverse Event Report

CHIRON VISION CORP CHIRON SITE TXR DIAPHRAGM SYSTEM PHACO EMULSIFICATION   back to search results
Model Number 501-1045
Event Date 04/16/1996
Patient Outcome  Required Intervention;
Event Description

During 2nd pass of phaco emulsification at 16 seconds, a white spot was noted to be forming over the tunnel of the limbus; irrigant flowing freely prior to entry and after removal; handpiece changed; on 2nd pass with this a brownish discoloration was noted over the previous white spot at the limbus; machine changed, handpiece changed; as threr had been apparent shrinkage of collagen in the tunnel, procedure converted to a extracapsular with no further difficulty.

 
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Brand NameCHIRON SITE TXR
Type of DeviceDIAPHRAGM SYSTEM PHACO EMULSIFICATION
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CHIRON VISION CORP
500 io lab dr
claremont CA 91711
Manufacturer (Section D)
CHIRON VISION CORP
500 io lab dr
claremont CA 91711
Device Event Key85019
MDR Report Key85806
Event Key80742
Report Number85806
Device Sequence Number1
Product CodeHQC
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/18/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number501-1045
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/16/1996
Device Age10 yr
Event Location Hospital
Date Report TO Manufacturer04/25/1996
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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