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Adverse Event Report

ALCON ALCON PHACO MACHINE   back to search results
Model Number LEGACY 2000
Event Description

Handpiece overheated resulting in mild corneal burn. No sequelae.

 
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Brand NameALCON
Type of DevicePHACO MACHINE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
ALCON
dallas TX *
Device Event Key379968
MDR Report Key390921
Event Key369234
Report NumberMW1024829
Device Sequence Number1
Product CodeHQC
Report Source Voluntary
Report Date 04/29/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberLEGACY 2000
Was Device Available For Evaluation? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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