MAUDE MDR 1764458

MDR report key
1764458
Report number
1764458
Event key
0
Event type
3
Date of event
2010-05-12
Date received
2010-05-18
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
1ICARE TONOMETER - ICARE FINLAND OYICARE TONOMETER AND PROBESICARE FINLAND OYHKX*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-05-1801. O

Event Narratives#

D

Patient 1

I AM A LICENSED OPTOMETRIST IN THE STATE OF (B)(6) WHO USES A PRODUCT CALLED THE ICARE TONOMETER AS A GLAUCOMA SCREENING TOOL IN MY OFFICE. I HAVE BECOME AWARE OF INFORMATION THAT I FEEL SHOULD BE MADE KNOWN TO MORE PEOPLE THAN MYSELF. I USE THIS INSTRUMENT TO DETERMINE IF A PERSON'S INTRAOCULAR PRESSURE IS WITHIN NORMAL LIMITS. IF, IN FACT, THESE PROBES ARE NOT THE FDA APPROVED PROBES, THEN THE VALUES I AM RELYING ON ARE NOT ACCURATE. IF THIS IS TRUE THEN THE POSSIBILITY EXISTS THAT I WOULD MISS AN EARLY GLAUCOMA OR OCULAR HYPERTENSIVE PATIENT. THIS INVITES A BEVY OF PROBLEMS NOT INCLUDING HARM TO THE PATIENT, MALPRACTICE IMPLICATIONS, INCORRECT DECISIONS ON PATIENT CARE, AND LOSS OF INVESTMENT IN THE TONOMETER ITSELF. INCLUDED IS A COPY OF ALL EVIDENCE I HAVE OBTAINED INDICATING THESE PROBES ARE NOT THE ORIGINAL PROBES AS APPROVED BY THE FDA. IF THESE ARE ALSO BEING UTILIZED BY OTHER DOCTORS, THIS ERROR IS BEING COMPOUNDED. I INCLUDE MY NAME, PHONE NUMBER, AND COPIES OF ALL MY DOCUMENTS. YOU DO WITH THIS INFORMATION AS YOU SEE FIT, FOR NOW, I WILL USE MY SUPPLY OF ORIGINAL PROBES, THEN STOP USE OF THE INSTRUMENT AS I FEEL I HAVE NO OTHER CHOICE. THE END USERS OF THIS PRODUCT WERE NOT MADE AWARE OF THIS SUBSTITUTION, AS I DOUBT YOU WERE, AND THEREIN LIES THE PROBLEM.