FDA.reportPublic FDA data

MAUDE MDR 431525

MDR report key
431525
Report number
2918630-2002-00004
Event key
0
Event type
3
Date of event
2000-08-18
Date received
2002-12-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
5160 HACIENDA DRIVE DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ATLAS CORNEAL TOPOGRAPHY SYSTEMCORNEAL MAPPERCARL ZEISS MEDITEC INCHJB992992-02NANNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-12-0401. R

Event Narratives#

D

Patient 1

THE REPORTER; AN ATTORNEY, REPRESETING A PATIENT STATED THAT THE PATIENT HAD LASIK SURGERY ON BOTH EYES IN 2000. PRIOR TO SURGERY, THE USER FACILITY EVALUATED THE PATIENT FOR CANDIDACY FOR SURGERY, INCLUDING EVALUATION WITH THE SUBJECT DEVICE. SINCE THE SURGERY, THE PATIENT ALLEGES INJURIES AND DAMAGES TO THEIR EYES.