FDA.reportPublic FDA data

MAUDE MDR 1005045

MDR report key
1005045
Report number
9615030-2008-00001
Event key
0
Event type
3
Date of event
2008-01-28
Date received
2008-02-29
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
CARL ZEISS PROMENADE 10 JENA GM
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IOL MASTERSLITLAMP, BIOMICROSCOPECARL ZEISS MEDITEC AGHJOIOL5-12NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-02-290

Event Narratives#

N

Patient 1

THE IOL MASTER WAS INSPECTED BY A SERVICE TECHNICIAN AND FOUND TO BE OPERATING PROPERLY AND WITHIN CALIBRATION. THE SITE'S PERSONNEL WERE INSTRUCTED IN PROPER OPERATION OF THE INSTRUMENT BY THE SERVICE TECH AND A CLINICAL APPLICATION SPECIALIST.

D

Patient 1

A PT REQUIRED SURGERY TO REMOVE A PREVIOUSLY IMPLANTED INTRAOCULAR LENS (18.5 DIOPTERS) AND TO IMPLANT A DIFFERENT INTRAOCULAR LENS (20.9 DIOPTERS).