FDA.reportPublic FDA data

MAUDE MDR 2743849

MDR report key
2743849
Report number
9615030-2012-00003
Event key
0
Event type
3
Date of event
2012-05-15
Date received
2012-09-12
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#

Contact
JUDY BRIMACOMB
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
1IOLMASTERBIOMICROSCOPE, SLIT-LAMP, AC-POWEREDCARL ZEISS MEDITEC AG (JENA SITE)HJONAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-09-1201. R

Event Narratives#

D

Patient 1

A PATIENT REQUIRED SURGERY TO REMOVE A PREVIOUSLY IMPLANTED INTRAOCULAR LENS (UNKNOWN DIOPTERS) AND TO IMPLANT AN INTRAOCULAR LENS WITH DIFFERENT POWER (UNKNOWN DIOPTERS). IT WAS REPORTED THAT THE DOCTOR DISCOVERED AFTER THE SURGERY THAT IOL CALCULATION WAS WRONG.

N

Patient 1

A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE EVALUATION OF THE IOLMASTER INSTRUMENT. CALIBRATION AND OPERATION WERE VERIFIED. THE SITE HAS NOT YET RESPONDED TO REQUESTS FOR INFORMATION REGARDING THE PATIENT (SECTION A) AND PREOPERATIVE AND POSTOPERATIVE DATA.