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MAUDE Adverse Event Report: LASIK EYE CENTER LASIK PLUS
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LASIK EYE CENTER LASIK PLUS
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Device Problem
Insufficient Information (3190)
Patient Problems
Emotional Changes (1831); Anxiety (2328); Depression (2361)
Event Date
01/06/2010
Event Type
Injury
Event Description
I had lasik eye surgery at lasik plus and my life hasn't been the same since. Suicidal and etc now.
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Brand Name
LASIK PLUS
Type of Device
LASIK PLUS
Manufacturer
(Section D)
LASIK EYE CENTER
MDR Report Key
3370439
MDR Text Key
3715978
Report Number
MW5031983
Device Sequence Number
1
Product Code
LZS
Combination Product (Y/N)
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
PATIENT
Type of Report
Initial
Report Date
09/20/2013
1
Device Was Involved in the Event
1
Patient Was Involved in the Event
Date FDA Received
09/23/2013
Is This An Adverse Event Report?
Yes
Is This A Product Problem Report?
No
Device Operator
HEALTH PROFESSIONAL
Patient TREATMENT DATA
Date Received: 09/23/2013 Patient Sequence Number: 1
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