FDA.reportPublic FDA data

MAUDE MDR 1149362

MDR report key
1149362
Report number
9615030-2008-00003
Event key
0
Event type
3
Date of event
2008-05-16
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 AGHJOIOL3-02Y Y

Patients#

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

Event Narratives#

D

Patient 1

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

N

Patient 1

THE IOL MASTER WAS INSPECTED BY A SERVICE TECHNICIAN AND FOUND TO BE OPERATING WITHIN CALIBRATION SPECIFICATIONS. SERVICE TECHNICIAN NOTED THAT THE INSTRUMENT DOES NOT RETAIN THE DATE OR TIME SETTING AND NEEDS REPAIR. OFFICE DECLINED REPAIR. INFORMATION WAS NOT PROPERLY ENTERED INTO INSTRUMENT BY OFFICE STAFF: AN A-CONSTANT WAS ENTERED AS 119.7 ALTHOUGH IT SHOULD HAVE BEEN ENTERED AS 119.2; ANOTHER A-CONSTANT WAS ENTERED AS 119.2 ALTHOUGH IT SHOULD HAVE BEEN ENTERED AS 119.0. OFFICE STAFF DID NOT KNOW HOW TO PERFORM DAILY CALIBRATION WITH TEST EYE; THEREFORE, THIS PROCEDURE WAS NOT PERFORMED. THE USER'S MANUAL STATES THAT CALIBRATION SHOULD BE CHECKED DAILY WITH THE TEST EYE.