FDA.reportPublic FDA data

MAUDE MDR 688841

MDR report key
688841
Report number
2918630-2006-00001
Event key
0
Event type
3
Date of event
2006-02-14
Date received
2006-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KENT JONES
Address
5160 HACIENDA DR DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STRATUS OCTOPTICAL COHERENCE TOMOGRAPHY SCANNERCARL ZEISS MEDITEC, INC.HLI3000**K030433NNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-03-1301. O

Event Narratives#

D

Patient 1

PATIENT UNDERWENT ROUTINE EYE EXAMINATIONS FOR GLAUCOMA, INCLUDING STRATUS OCT IMAGING. WHILE UNDERGOING THE PROCEDURE,THE PATIENT COMPLAINED OF BEING BOTHERED BY THE BRIGHT LIGHT EMITTED BY THE INSTRUMENT DURING SCANNING. SHORTLY THEREAFTER , PATIENT HAD AN EPISODE OF SEIZURE DESCRIBED AS DISORIENTATION, UNRESPONSIVENESS, AND MUSCLE CONTRACTIONS WITHOUT TONGUE BITING AND INCONTINENCE LASTING APPROXIMATELY 45 SECONDS. UPON EXAMINATION BY A PARAMEDIC, PATIENT WAS TAKEN TO AN EMERGENCY ROOM FOR FURTHER CARE. NO UNTOWARD SEQUELAE WERE NOTED AFTER THE INCIDENT.