ICARE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for ICARE manufactured by Icare Finland Oy.

Event Text Entries

[137547840] I went to the eye doctor for reading glasses. I was tested for glaucoma. An employee did the testing. I have found out that an instrument called icare was used (as stated in the medical record, per (b)(6)) (i thought it was an instrument called a corneal pachymetry, which was listed in their brochure. The icare is not listed in the brochure). I felt 4 pinpoints of pain, simultaneously, in each eye as the test was performed. Drops were not given previous to the test. I have accessed (b)(6) and it shows the icare 100 as having individual readings, having to press the button for each 6 times. It shows what looks to be a cone spray of air. So, i am reporting the icare; it must have malfunctioned. In addition, on (b)(6) 2019, in the evening about 10pm, as i lay waiting for sleep, i felt the right eye expand, like a sea anemone opening its petals. Gentle, fluid like, and individual like motion. Not the whole eyeball, but the colored part. I did not ever feel the left eye do this, although it may have happened while sleeping. I have an appointment with dr. (b)(6), ophthalmologist, of (b)(6) eye care on (b)(6). You may access his records for any relevant findings. My visit is primarily for feeling a foreign object in the left eye, which i have felt off and on since (b)(6). Also, because i have added, in (b)(6), flonase to my list of medicines, and it is recommended to check with your doctor. In addition, i will discuss with him my experience on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084444
MDR Report Key8374851
Date Received2019-02-26
Date of Report2019-02-24
Date of Event2018-12-17
Date Added to Maude2019-02-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameICARE
Generic NameTONOMETER, MANUAL
Product CodeHKY
Date Received2019-02-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerICARE FINLAND OY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-26

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