FDA.reportPublic FDA data

MAUDE MDR 5471820

MDR report key
5471820
Report number
9615030-2016-00001
Event key
0
Event type
3
Date of event
2016-02-02
Date received
2016-03-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. WILLIAM GUSTAFSON
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
1IOLMASTER 700BIOMICROSCOPE, SLIT-LAMP, AC-POWERED, PRODUCT CODE: HJOCARL ZEISS MEDITEC AG (JENA)HJONA000000-1932-169NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-0101. O

Event Narratives#

N

Patient 1

NARRATIVE: THE MANUFACTURER EVALUATED THE DAILY CALIBRATION CHECKS AND THE LOG FILES FROM THE IOLMASTER 700. THE MANUFACTURER DID NOT FIND ABNORMALITIES AND CONFIRMED THAT THE DEVICE OPERATES WITHIN SPECIFICATIONS. INFORMATION REGARDING THE MEASURED VALUES WITH ULTRASOUND BIOMICROSCOPE (UBM) MEASUREMENTS WERE NOT PROVIDED BY THE CUSTOMER. THE UBM IS USED FOR MEASURING THE SULCUS TO SULCUS DISTANCE. THESE VALUES CAN DIFFER FROM THE DIAMETER OF THE IRIS (WTW).

D

Patient 1

THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THE FOLLOWING: THE POST SURGICAL OUTCOME FOR AN EYE CATARACT SURGERY WITH AN INTRAOCULAR CHAMBER LENS (ICL IOL) WAS INCREASED EYE PRESSURE. THE IOLMASTER 700 WAS USED FOR THE ORIGINAL BIOMETRY MEASUREMENTS AND IOL CALCULATIONS AS WELL AS FOR THE SECOND MEASUREMENTS AND CALCULATIONS. THE HCP REPORTED THAT THE PATIENT'S PRE-OP WHITE-TO-WHITE MEASUREMENT (WTW) FROM THE IOLMASTER 700 DIFFERED FROM MULTIPLE FOLLOW-UP MEASUREMENTS PERFORMED WITH IOLMASTER 700 AND ULTRASONIC BIOMICROSCOPE (UBM) MEASUREMENT. THE HCP DETERMINED THAT THE INCREASED PRESSURE WAS DUE TO THE SIZE OF THE ICL IOL AND MADE A DECISION TO EXCHANGE THE LENS WITH A DIFFERENT SIZE ICL IOL.