FDA.reportPublic FDA data

MAUDE MDR 5767742

MDR report key
5767742
Report number
9615030-2016-00007
Event key
0
Event type
3
Date received
2016-07-03
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
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 700BIOMICROSCOPE, SLIT-LAMP, AC-POWERED, PRODUCT CODE: HJOCARL ZEISS MEDITEC AG (JENA)HJONA000000-1932-169NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-0301. O

Event Narratives#

N

Patient 1

NARRATIVE: A ZEISS CLINICAL APPLICATION SPECIALIST (CAS) EVALUATED ON-SITE THE CUSTOMER'S WORKFLOW AND THE PATIENT MEASUREMENT AND CALCULATION PRINTOUTS. THE CAS DETERMINED THAT THE HCP ENTERED THE SRK-T LENS CONSTANT INSTEAD OF THE MANUFACTURER A CONSTANT FOR CALCULATING THE FORMULA SPECIFIC LENS CONSTANTS, WHICH THEN LED TO THE INCORRECT IOL POWER CALCULATION. THE CAS DEMONSTRATED THAT THE CORRECT MANUFACTURER A CONSTANT VALUE WOULD HAVE LED TO THE DESIRED RESULT AND RETRAINED THE HCP. HOW TO USE THE IOLMASTER 700 FOR IOL CALCULATION AND HOW TO USE THE LENS CONSTANTS IS DESCRIBED IN THE USER MANUAL. FOR INSTANCE ON PAGE 53 OF USER MANUAL 00000-1932-169 IT IS STATED "THE IOL CALCULATION IS VALID ONLY IF THE BIOMETRIC MEASUREMENT WAS CORRECT, AN APPROPRIATE IOL CALCULATION FORMULA WAS SELECTED AND THE IOL CONSTANTS WERE OPTIMIZED FOR THE SPECIFIC APPLICATION." A WARNING MESSAGE IS GIVEN ON PAGE 76 WITH "CONSTANTS SUBJECT TO THE LENS TYPE MUST BE DEFINED AND ENTERED PRIOR TO USING THE IOLMASTER 700." AND WITH "THE CONSTANTS SHOULD THUS BE SUBJECTED TO REGULAR REVIEW AND REFINEMENT." THE DEVICE MANUFACTURE DATE FOR IOLM 700 S/N (B)(4) IS 12/2015 AND FOR IOLM 700 S/N (B)(4) IT IS 05/2016. THE MANUFACTURER RECEIVED DIFFERENT INFORMATION FROM THE CUSTOMER, WHICH INSTRUMENT WAS INVOLVED IN THE INCIDENT.

D

Patient 1

THIS IS CASE ONE OF TWO REPORTED CASES FROM SAME CUSTOMER SITE. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE POST REFRACTIVE OUTCOME AFTER A CATARACT SURGERY USING AN AMO TECHNIS INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED BY 2.5 DIOPTERS FROM THE TARGET REFRACTION. IT WAS FURTHER REPORTED THAT LASIK SURGERY TO IMPROVE THE VISUAL ACUITY IS PLANNED. NO FURTHER INFORMATION REGARDING THE PATIENT AND INCIDENT COULD BE OBTAINED. THE HCP USED THE IOLMASTER 700 FOR THE BIOMETRY MEASUREMENTS AND IOL CALCULATIONS.