ICARE TONOMETER - ICARE FINLAND OY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-05-18 for ICARE TONOMETER - ICARE FINLAND OY manufactured by Icare Finland Oy.

Event Text Entries

[1606524] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1764458
MDR Report Key1764458
Report Source99
Date Received2010-05-18
Date of Report2010-05-13
Date of Event2010-05-12
Date Facility Aware2010-05-12
Report Date2010-05-13
Date Reported to FDA2010-05-13
Date Added to Maude2010-07-27
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameICARE TONOMETER - ICARE FINLAND OY
Generic NameICARE TONOMETER AND PROBES
Product CodeHKX
Date Received2010-05-18
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerICARE FINLAND OY
Manufacturer AddressLAUTASSARENTIE 30 E HELSINK F0-00200 FI F0-00200


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-05-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.