FDA.reportPublic FDA data

MAUDE MDR 8376419

MDR report key
8376419
Report number
9615030-2019-00002
Event key
0
Event type
3
Date of event
2019-01-28
Date received
2019-02-27
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. VERNON BROWN
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
1MEL80 EXCIMER LASER SYSTEMEXCIMER LASER SYSTEMCARL ZEISS MEDITEC AG (JENA)LZSN/A1429-382N/AN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-2701. R

Event Narratives#

N

Patient 1

THE USER MANUAL DESCRIBES THE HANDLING OF THE FLUENCE TEST AS WELL AS THE TREATMENT. THE DEVICE EXECUTES ALL FUNCTIONS AS DESCRIBED IN THE MANUAL AND THE DOCTOR CAN FOLLOW THE PROGRESS OF THE FLUENCE TEST ON THE MONITOR IF THE TEST IS ACTIVATED

D

Patient 1

THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT, HE PERFORMED THE FLUENCE TEST PROCEDURE ON A PATIENT'S EYE, WHICH IS REQUIRED TO BE CARRIED OUT ON THE MEL80 EXCIMER LASER SYSTEM PRIOR TO STARTING THE TREATMENT. THE DOCTOR WILL PERFORM AN ADDITIONAL SURGERY TO CORRECT PATIENT'S VISION.