Description of Event or Problem · 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.