TONOPEN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-19 for TONOPEN manufactured by .

Event Text Entries

[17264962] An eye technician at the eye doctor performed a glaucoma test using a tonopen. The tonopen was not holding a battery charge so she hit my eyeball multiple times very hard to obtain the reading. After the numbing drops wore off i had persistent eye pain that lasted for months. When i called the office i learned that i was not the first and that this occurred in one pt every couple of months. In my opinion standard eye exam should not cause problems. It has been 5 months and the pain is there on and off and i have developed a long hair like floater in the center of the injured eye. Since the tonopen test, i have visited the eye dr 5 times and have fears about my eyesight deteriorating, my job and enjoyment in life. Since there are so many different ways to test for glaucoma, i would personally like to see the tonopen removed from the market. I am guessing that the handheld pen is an inexpensive device that brings the most profit. If the fda keeps the tonopen they should not allow technicians to do the test as it is too simple to injure the eye. In summary i went to the doctor to see if i needed reading glasses and came away with damage and pain to the eye. Please remove the tonopen from market so that this does not happen to others. Thank you.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5036185
MDR Report Key3829801
Date Received2014-05-19
Date of Report2014-05-16
Date of Event2013-12-24
Date Added to Maude2014-05-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTONOPEN
Generic NameTONOMETER, MANUAL
Product CodeHKY
Date Received2014-05-19
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-05-19

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