MAUDE MDR 5478523

MDR report key
5478523
Report number
9615030-2016-00002
Event key
0
Event type
3
Date received
2016-03-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1IOLMASTERBIOMICROSCOPE, SLIT-LAMP, AC-POWERED, PRODUCT CODE: HJOCARL ZEISS MEDITEC AG (JENA)HJONA000000-1322-734NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-0301. O

Event Narratives#

N

Patient 1

A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE EXAMINATION OF THE IOLMASTER. NO DEVIATION IN THE READINGS FOR AXIAL LENGTH, KERATOMETRY, ANTERIOR CHAMBER DEPTH, OR WHITE-TO-WHITE WERE FOUND. THE HEALTHCARE PROVIDER MADE A DECISION TO PROCEED WITH THE ORIGINAL IMPLANTATION ALTHOUGH THE MEASUREMENT PRINTOUT SHOWED DIFFERENT OD AND OS K-VALUES AND INCLUDED THE REMARK: "THE KER- READINGS SHOULD BE CHECKED FOR PLAUSIBILITY, AS THERE MIGHT BE PATHOLOGICAL CHANGES." THE QUALITY OF THE K-MEASUREMENT HIGHLY DEPENDS UPON THE QUALITY OF THE TEAR FILM, CORRECT FIXATION AND WIDE OPEN EYES.

D

Patient 1

THE HEALTH CARE PROFESSIONAL REPORTED THE FOLLOWING: THE POST REFRACTIVE OUTCOME FOR AN EYE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION WAS OD -2.75 DIOPTERS. THE HEALTHCARE PROFESSIONAL MADE A DECISION TO EXCHANGE THE IOL. THE IOLMASTER WAS USED FOR THE ORIGINAL BIOMETRY MEASUREMENTS AND IOL CALCULATIONS AS WELL AS FOR THE SECOND BIOMETRY MEASUREMENTS AND CALCULATIONS.