MAUDE MDR 1717016

MDR report key
1717016
Report number
1717016
Event key
0
Event type
3
Date of event
2010-01-26
Date received
2010-05-04
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#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IOLMASTERINTRAOCULAR LENS TESTINGCARL ZEISSHLMV 4.08** Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-05-040

Event Narratives#

D

Patient 1

IOL MASTER SCREENING WAS DONE PRE-OP FOR CATARACT SURGERY, R EYE READING ACCURATE, L EYE READING INNACCURATE BUT NO ALARM OR HIGHLIGHT RELATED TO THE SIZE DISCREPANCY. CATARACT SIZE ORDERED AS INDICATED BY TEST RESULT AND ON POST OP DAY ONE PATIENT FOUND TO HAVE WORSE VISION AND IT WAS DETERMINED THAT THE WRONG SIZE LENS WAS IMPLANTED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================INSTEAD OF REJECTING A FALSE MEASUREMENT, THE MACHINE USED IT TO INCORRECTLY CALCULATE A WRONG LENS IMPLANT SIZE. THIS IS BECAUSE WHEN THE CATARACT IS TOO DENSE, THE IOLMASTER CAN NOT GIVE AN ACCURATE MEASUREMENT. INSTEAD OF REPORTING AN ERRONEOUS MEASUREMENT, IT SHOULD INDICATE THE NEED FOR A DIFFERENT TEST. IT MAY BE HELPFUL TO ALLOW FOR CALIBRATION OF THE SOFTWARE IF THE TEST IS INACCURATE. THE PHYSICIAN REALIZES THERE ARE HUMAN FACTORS INVOLVED BUT FEELS THERE COULD BE AN IMPROVEMENT TO THE SOFTWARE/REPORTING OUT OF RESULTS.