FDA.reportPublic FDA data

MAUDE MDR 424973

MDR report key
424973
Report number
2918630-2002-00002
Event key
0
Event type
3
Date of event
2002-07-12
Date received
2002-10-28
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#

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
1ULTRASONIC BIOMETERLENS MEASURING INSTRUMENTCARL ZEISS MEDITEC INCHJB820NANANNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-10-2801. R

Event Narratives#

D

Patient 1

THE INCIDENT INVOLVED THE ULTRASONIC BIOMETER. THIS WAS GIVING THE WRONG CALCULATION RESULTING IN 8 INCORRECT SURGERIES. THE EIGHT PTS ARE ENDING UP WITH FARSIGHTED RESULTS WITH AN ERROR OF 2.0 DIOPTERS. IT HAS BEEN REPORTED, AFTER EXAMINING THE PTS' EXAM PRINTOUT, THAT THE DOCTOR NOTICED THE A-CONSTANT DID NOT MATCH THE LENS THEY WERE USING BEFORE, WHICH WAS CAUSING THE MISCALCULATION. AT THE TIME THE INCIDENT WAS REPORTED, THE USER FACILITY STATED THAT THE INSTRUMENT NOW HAS THE CORRECT A-CONSTANT, AND IS OPERATING WITHIN SPECIFICATIONS. DOCTOR CLAIMED THAT MANUFACTURER'S SERVICE REP ENTERED THE A-CONSTANT DURING THE LAST SERVICE CALL BUT ONLY THE DOCTOR WOULD KNOWN THE CORRECT A-CONSTANT.