LASIK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-10 for LASIK manufactured by .

Event Text Entries

[65003108] I had lasik surgery on my left eye on (b)(6) 2016, and had only minor side effects but then on (b)(6) 2016, i had surgery in the right eye and the problems started soon after. Last week i went to see my optometrist, the one who referred me to the eye surgeon for lasik because i am suffering from flashes, floaters, and weird stuff in my right eye, the eye that was done last. I also get pain in the eye and feel pressure. My optometrist, not the physician who did the lasik, examined me last friday and said it had to do with migraines. I have never had a migraine. Last night, i could not sleep because of the discomfort and because i worked as a research analyst most of my life, i research the problem and voila here it is.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5067226
MDR Report Key	6249439
Date Received	2017-01-10
Date of Report	2017-01-10
Date of Event	2017-01-01
Date Added to Maude	2017-01-13
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	0
Reprocessed and Reused Flag	3
Reporter Occupation	PATIENT
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	0

Device Sequence Number: 0

Brand Name	LASIK
Generic Name	LASIK
Product Code	LQJ
Date Received	2017-01-10
Operator	LAY USER/PATIENT
Device Availability	Y
Device Eval'ed by Mfgr	*
Device Sequence No	0
Device Event Key	0

Device Sequence Number: 1

Brand Name	LASIK
Generic Name	LASIK
Product Code	OJK
Date Received	2017-01-10
Operator	LAY USER/PATIENT
Device Availability	Y
Device Eval'ed by Mfgr	*
Device Sequence No	1
Device Event Key	0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2017-01-10