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 2010-05-19 for ICARE TONOMETER - ICARE FINLAND OY manufactured by Icare Finald Oy.

Event Text Entries

[1492193] 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 info 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 pt. This invites a bevy of problems not including harm to the pt, malpractice implications, incorrect decisions on pt 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 Number: 1698226
• MDR Report Key: 1698226
• Report Source: 99
• Date Received: 2010-05-19
• Date of Report: 2010-05-13
• Date of Event: 2010-05-12
• Date Facility Aware: 2010-05-13
• Report Date: 2010-05-13
• Date Reported to FDA: 2010-05-13
• Date Added to Maude: 2010-05-26
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ICARE TONOMETER - ICARE FINLAND OY
• Generic Name: ICARE TONOMETER & PROBES
• Product Code: HKY
• Date Received: 2010-05-19
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ICARE FINALD OY
• Manufacturer Address: LAUTTASAARENTIE 50E HELSINKI FI-00200 FI FI-00200

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2010-05-19