FDA.reportPublic FDA data

MAUDE MDR 2869760

MDR report key
2869760
Report number
9615030-2012-00006
Event key
0
Event type
3
Date of event
2012-11-14
Date received
2012-12-10
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#

Address
CARL ZEISS PROMENADE 10 JENA 07745 GM
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IOLMASTERBIOMICROSCOPE, SLIT-LAMP, AC-POWERED20CARL ZEISS MEDITEC AG (JENA SITE)HJO500000001-5683-281Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-12-100

Event Narratives#

D

Patient 1

DOCTOR REPORTED THAT BIOMETRIC DATA COLLECTED WITH A NEW IOLMASTER CONSISTENTLY VARIED FROM DATA COLLECTED WITH ULTRASOUND (IMMERSION). AFTER SEEING THE VARIATION THE DOCTOR CHOSE TO NOT USE THE IOLMASTER DATA. THE DOCTOR REPORTED THAT USE OF THE ULTRASOUND DATA RESULTED IN IOL IMPLANTATIONS WITH SUCCESSFUL OUTCOMES.