FDA.reportPublic FDA data

MAUDE MDR 6341762

MDR report key
6341762
Report number
9615030-2017-00003
Event key
0
Event type
3
Date of event
2017-01-17
Date received
2017-02-17
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
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)HJONA000000-1692-983NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-1701. O

Event Narratives#

N

Patient 1

A ZEISS FIELD SERVICE ENGINEER INSPECTED THE DEVICE AND CONFIRMED THAT THE IOLMASTER 500 IS OPERATING PER MANUFACTURER SPECIFICATION. THE MANUFACTURER EVALUATED THE PATIENT MEASUREMENT AND IOL CALCULATION PRINTOUTS FROM THE DEVICE. THE MEASUREMENT PRINTOUT DOES NOT SHOW ANY ABNORMALITIES. DURING THE INVESTIGATION, THE CUSTOMER INFORMED THAT THE LENS CONSTANTS FOR THE SELECTED IOL WERE ENTERED MANUALLY IN THE IOLMASTER 500 AND THE WRONG ACD CONSTANT WAS ENTERED IN THE HOLLADAY 2 FORMULA FIELD. BY REVIEWING THE CALCULATION PRINTOUT, THE MANUFACTURER CONFIRMED THAT THE ACD CONSTANT FOR HOLLADAY 1 WAS ENTERED INTO THE HOLLADAY 2 FORMULA FIELD, WHICH CAUSED THE INCORRECT LENS POWER RESULT. WHEN USING THE CORRECT ACD CONSTANT OF 5.838, THE CALCULATED LENS POWER WOULD HAVE BEEN 23.0 D FOR THE IOL; INSTEAD ACD CONSTANT 2.070 WAS USED, WHICH LED TO A LENS POWER OF 17.0 D. HOW TO USE THE LENS CONSTANTS IS DESCRIBED IN THE USER MANUAL. FOR EXAMPLE, ON PAGE 25 OF USER MANUAL 000000-1692-983 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 +4.0 D FROM THE TARGET REFRACTION. THE ALCON ACRYSOF IQ RESTOR MODEL SV25T0 LENS WITH A POWER OF 17.0 D WAS USED. THE HCP INFORMED THAT A RE-OP WAS PERFORMED TO EXCHANGE THE LENS. THE SAME LENS WITH A POWER OF 23.0 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.