FDA.reportPublic FDA data

MAUDE MDR 6473181

MDR report key
6473181
Report number
9615030-2017-00006
Event key
0
Event type
3
Date of event
2016-04-30
Date received
2017-04-07
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
MR. 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 500BIOMICROSCOPE, SLIT-LAMP, AC-POWEREDCARL ZEISS MEDITEC AG (JENA)HJONA000000-1794-857NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-0701. O

Event Narratives#

N

Patient 1

THE CUSTOMER CONFIRMED THAT THE IOLMASTER 500 PASSED THE DAILY CALIBRATION CHECKS. THE CUSTOMER DID NOT OBSERVE ANY DEVIATIONS IN THE READINGS FOR AXIAL LENGTH, KERATOMETRY, ANTERIOR CHAMBER DEPTH AND WHITE TO WHITE. BASED ON THE SUCCESSFUL DAILY CALIBRATION CHECKS AND THE ACCURATE READINGS CONFIRMED BY THE CUSTOMER, THE MANUFACTURER CONCLUDED THAT THE IOLMASTER 500 WAS WORKING WITHIN SPECIFICATION. THE MANUFACTURER EVALUATED THE PATIENT MEASUREMENT AND IOL CALCULATION PRINTOUTS FROM THE DEVICE. THERE ARE NO LENS CONSTANTS AVAILABLE ON THE ULIB WEBPAGE FOR THE ALCON ARCYSOFT IQ LENS USED. THE MANUFACTURER DETERMINED THAT THE HCP MANUALLY ENTERED THE LENS CONSTANT WITH A LEADING NEGATIVE SIGN FOR THE ALCON ARCYSOFT IQ LENS INTO THE IOLMASTER 500 CAUSING THE REFRACTIVE OUTCOME. THE LENS CONSTANT USED BY THE HCP IS (AMONG OTHER CONSTANTS) A2= -0.204. LENSES SIMILAR TO ARCYSOFT IQ TYPICALLY HAVE A LEADING POSITIVE SIGN FOR THE A2 CONSTANT. THE DIFFERENCE IN THE LEADING SIGN COULD LEAD TO A SIGNIFICANT VARIATION IN THE REFRACTIVE OUTCOME. HOW TO USE THE LENS CONSTANTS IS DESCRIBED IN THE USER MANUAL. FOR EXAMPLE, ON PAGE 25 OF USER MANUAL 000000-1692-983_SWGA_GB_280111, IT IS STATED "ONLY LENS CONSTANTS WHICH HAVE BEEN OPTIMIZED FOR THE IOLMASTER SHOULD BE USED" AND "YOU CAN ENTER YOUR OWN CONSTANTS ON THE BASIS OF EXPERIENCE OR ACCESS THIRD PARTY DATA". ON PAGES 26-30, THE USER MANUAL PROVIDES STEP-BY-STEP INSTRUCTIONS FOR BOTH OF THESE METHODS.

D

Patient 1

THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THE FOLLOWING: THE OS POST REFRACTIVE OUTCOME AFTER A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED +6.0 D FROM THE CALCULATED TARGET REFRACTION. THE ALCON ACRYSOFT IQ LENS WITH A POWER OF 7.5 D WAS USED. THE HCP INFORMED THAT A RE-OP WAS PERFORMED TO EXCHANGE THE LENS. THE SAME LENS WITH A POWER OF 18.5 D WAS USED FOR THE RE-OP. THE IOLMASTER WAS USED FOR THE ORIGINAL BIOMETRY MEASUREMENTS AND IOL CALCULATIONS AS WELL AS FOR THE SECOND BIOMETRY MEASUREMENTS AND CALCULATIONS.