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Adverse Event Report

CHIRON VISION CORP. CATALYST CONSOLE EQUIPMENT   back to search results
Catalog Number 504-2200
Event Date 04/02/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Doctor experienced intermittent power which resulted in a choroidal hemorrage.

 
Manufacturer Narrative

A 2-4 patient information unavailable. F section completed by manufacturer. 2203, other, choroidal, hemmorrage, unlabeled. 2203, other, intermittent power, unlabeled. 2203, other, intermittent vacuum, unlabeled.

 
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Brand NameCATALYST CONSOLE
Type of DeviceEQUIPMENT
Baseline Brand NameCATALYST SYSTEM ROTARY VANE DOMESTIC
Baseline Generic NameUNIT, PHACOFRAGMENTATION
Baseline Catalogue Number504-2200
Baseline Device FamilyHQC-UNIT, PHACOFRAGMENTATION
Baseline Device 510(K) NumberK834159
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed12/18/1983
Manufacturer (Section F)
CHIRON VISION CORP.
9342 jeronimo road
irvine CA 92718 1903
Manufacturer (Section D)
CHIRON VISION CORP.
9342 jeronimo road
irvine CA 92718 1903
Manufacturer (Section G)
BAUSCH & LOMB SURGICAL, INC.
555 west arrow hwy.
claremont CA 91711
Manufacturer Contact
christine jordan
500 iolab dr
claremont , CA 91711
(909) 399 -1600
Device Event Key88218
MDR Report Key89234
Event Key83888
Report Number2023366-1997-00017
Device Sequence Number1
Product CodeHQC
Report Source Manufacturer
Source Type User facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 05/05/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/05/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number504-2200
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/11/1997
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/02/1997
Event Location Hospital
Date Manufacturer Received04/02/1997
Was Device Evaluated By Manufacturer? Yes
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 30, 2009

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