FDA.reportPublic FDA data

MAUDE MDR 7700933

MDR report key
7700933
Report number
9615030-2018-00003
Event key
0
Event type
3
Date received
2018-07-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. WILLIAM GUSTAFSO
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-POWEREDCARL ZEISS MEDITEC AG (JENA)HJONA000000-1932-169NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-1801. R

Event Narratives#

N

Patient 1

THIS MDR IS TO REPORT ALLEGATION OF INCORRECT HYPEROPIC SURGICAL OUTCOME OF AN ADDITIONAL PATIENT, FOR THE DEVICE ISSUE REPORTED UNDER MDR 9615030-2017-00025 AND 9615030-2017-00026. RETREATMENT OF THE PATIENT WAS NECESSARY DUE TO THE INCORRECT SURGICAL OUTCOME.

D

Patient 1

A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT HAD AN INCORRECT HYPEROPIC SURGICAL RESULT AFTER USING THE IOLMASTER 700 FOR BIOMETRY MEASUREMENTS AND LENS POWER CALCULATIONS. THE HCP REPORTED THAT THE PATIENT WILL HAVE LASIK SURGERY TO CORRECT HIS/HER VISION.