MAUDE MDR 4815093

MDR report key
4815093
Report number
MW5042929
Event key
0
Event type
3
Date received
2015-05-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GOLDMANN TONOMETERGOLDMANN TONOMETERHKY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-270

Event Narratives#

D

Patient 1

I AM WRITING TO YOU ABOUT A VERY SERIOUS MATTER WHICH CALLS FOR YOUR ATTENTION. THE FOLLOWING INFO WILL NOT HELP ME FOR I AM ALREADY DAMAGED "BLIND". MY CONDITION CAME ABOUT WHEN MY EYES UNDERWENT AN ABUSIVE EXAM WITHOUT INFORMED CONSENT AND ALCAINE SEDATIVE EYE DROPS - WHICH I LATER LEARNED "WILL CAUSE OPACIFICATION AND LOST OF SIGHT". THAT DAY I WAS ALSO GIVEN "COSOPT IN A SOLUTION OF MERCURY", EVEN THOUGH MY VISION WAS 20/20 PERFECT FARSIGHTED. THE MACHINE THE PUBLIC SHOULD BE WARNED ABOUT THE GOLDMAN TONOMETER. IT IS ABUSIVE, INTRAOCULAR PRESSURE - EVEN IF ONLY TEMPORARILY AND THAT'S NOT TRUE WITH REPEATED TESTING AND CAN TRIGGER GLAUCOMA, OR AGGRAVATE IT AND CAUSE BLINDNESS. MEDICAL PERSONNEL SHOULD BE MADE TO INFORM PEOPLE OF THESE RISK, IN A WRITTEN AND VERBAL STATEMENT. IT'S TOO LATE FOR ME - BUT YOU CAN HELP OTHER AMERICANS BY MAKING SURE THIS INFO GETS TOLD BY MEDICAL PERSONNEL TO ANYONE WHO COMES IN FOR ANY EYE EXAMS.