GOLDMANN TONOMETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-27 for GOLDMANN TONOMETER manufactured by .

Event Text Entries

[5916336] I am writing to you about a very serious matter which calls for your attention. The following info will not help me for i am already damaged "blind". My condition came about when my eyes underwent an abusive exam without informed consent and alcaine sedative eye drops - which i later learned "will cause opacification and lost of sight". That day i was also given "cosopt in a solution of mercury", even though my vision was 20/20 perfect farsighted. The machine the public should be warned about the goldman tonometer. It is abusive, intraocular pressure - even if only temporarily and that's not true with repeated testing and can trigger glaucoma, or aggravate it and cause blindness. Medical personnel should be made to inform people of these risk, in a written and verbal statement. It's too late for me - but you can help other americans by making sure this info gets told by medical personnel to anyone who comes in for any eye exams.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5042929
MDR Report Key4815093
Date Received2015-05-27
Date Added to Maude2015-06-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameGOLDMANN TONOMETER
Generic NameGOLDMANN TONOMETER
Product CodeHKY
Date Received2015-05-27
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2015-05-27

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