FDA.reportPublic FDA data

MAUDE MDR 1149363

MDR report key
1149363
Report number
9615030-2008-00002
Event key
0
Event type
3
Date of event
2008-06-18
Date received
2008-08-29
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#

Contact
KENT JONES
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
1IOL MASTERSLITLAMP, BIOMICROSCOPECARL ZEISS MEDITEC AGHJOIOL5-01Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-08-2901. O

Event Narratives#

N

Patient 1

THE IOL MASTER WAS INSPECTED BY A SERVICE TECHNICIAN AND FOUND TO BE OPERATING PROPERLY AND WITHIN CALIBRATION. SERVICE TECHNICIAN REVIEWED RECORDS AND FOUND THAT THE INITIAL MEASUREMENT INDICATED "EVALUATION" AND HAD A LOWER THAN OPTIMAL SIGNAL-TO-NOISE RATIO. THE MEASUREMENT SHOULD NOT HAVE BEEN USED. CUSTOMER INSTRUCTED IN PROPER OPERATION OF THE INSTRUMENT BY THE SERVICE TECHNICIAN.

D

Patient 1

A PATIENT REQUIRED A SECOND SURGERY TO CORRECT HER REFRACTIVE ERROR AFTER HER INITIAL SURGERY TO IMPLANT AN INTRAOCULAR LENS.