FDA.reportPublic FDA data

MAUDE MDR 428875

MDR report key
428875
Report number
2918630-2002-00003
Event key
0
Event type
3
Date of event
2002-10-14
Date received
2002-11-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

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

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ZEISS IOL MASTERIOL MASTER OPHTHALMIC DIAGNOSTICCARL ZEISS MEDITEC INCHJONAIOL-01NAK993357NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-11-1901. R

Event Narratives#

D

Patient 1

THE DEVICE WAS NOT MAKING ACCURATE MEASUREMENTS. THE MFR ASKED THE USER TO UTILIZE THE REFERENCE STANDARD (I.E. TEST EYE) THAT CAME WITH THE DEVICE TO VERIFY THE DEVICE PERFORMANCE AND CALIBRATION. USER STATED THEY NEVER RECEIVED THE TOOL OR THE USER MANUAL.