FDA.reportPublic FDA data

MAUDE MDR 5173671

MDR report key
5173671
Report number
9615030-2015-00008
Event key
0
Event type
3
Date of event
2015-09-29
Date received
2015-10-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JUDY BRIMACOMBE
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
1IOLMASTER 500BIOMICROSCOPE, SLIT-LAMP, AC-POWEREDCARL ZEISS MEDITEC AG (JENA)HJONA000000-1692-983NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-10-240

Event Narratives#

N

Patient 1

THE MANUFACTURER INVESTIGATED THE LOG FILES OF THE IOLMASTER 500 AND FOUND THAT THE HEALTHCARE PROVIDER HAD USED A SPECIFIC UNUSUAL WORKFLOW SEQUENCE. THE MANUFACTURER HAS DETERMINED THAT THIS WORKFLOW SEQUENCE COULD RESULT IN THE OBSERVED PROBLEM DUE TO A SOFTWARE ANOMALY. A DETERMINATION WAS MADE THAT THIS MALFUNCTION COULD POTENTIALLY LEAD TO THE SELECTION OF A SUB-OPTIMAL IOL IF NOT DETECTED BY THE HEALTHCARE PROVIDER.

D

Patient 1

IT WAS REPORTED THAT DURING A CATARACT CONSULT THE HEALTHCARE PROVIDER DISCOVERED THAT THE IOLMASTER 500 HAD PROVIDED THE WRONG INTRAOCULAR (IOL) CALCULATIONS FOR THE PATIENT WHEN USING THE MULTI-FORMULA FUNCTION. THE HEALTHCARE PROVIDER DETECTED THE ANOMALY BECAUSE THE IOL LENS POWER CALCULATIONS OF THE SECOND PRINTOUT DIFFER FROM WHAT WAS ON THE SCREEN. AS A RESULT, THE HEALTHCARE PROVIDER DID NOT USE THE DATA TO PERFORM IOL IMPLANTATION.