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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIGHT LASER TECHNOLOGIE AG WAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM

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LIGHT LASER TECHNOLOGIE AG WAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM Back to Search Results
Event Date 02/01/2006
Event Type  Injury  
Event Description

I had lasik surgery in (b)(6) 2006 and i have been struggling with complications since. Before my surgery i was assured i had < 1% chance of having gash or any other long term complications. I noted this on my consent form. Prior to the surgery i told the surgeon i have a very low tolerance for a bad outcome and gash. He repeatedly told me "pupil size is not a good predictor of poor post lasik night vision. " he assured me that as a "compatriot" he would take good care of me and that i "would do fine. " immediately following surgery, i developed dry eye which is worsening. I developed all the gash symptoms even though i was told i had < 1% chance of having any long term complications. The possibility of dry eye was never discussed with me. The only complications we discussed were gash because i initiated. After complaining about dry eye my surgeon told me i had dry eye before surgery. I thought this was a contraindication for lasik. Other contraindications for lasik: pre-existing dry eye, occupation -computer programmer-, large pupils, high correction, astigmatism, medications, long term contact lens use and possibly cataracts. I have been seeing the surgeon the entire time for follow ups, gash, dryness and cataracts with no resolution in sight. This has severely impacted my life to the point where my 3 yr relationship with my fiance ended. I am finding it very difficult to concentrate/work and i have become depressed as nothing helps and the drs are stumped.

 
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Brand NameWAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM
Type of DeviceWAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM
Manufacturer (Section F)
LIGHT LASER TECHNOLOGIE AG
wolfsmantel 5
erlangen
GERMANY 91058
Manufacturer (Section D)
LIGHT LASER TECHNOLOGIE AG
wolfsmantel 5
erlangen
GERMANY 91058
Device Event Key2055041
MDR Report Key2021735
Event Key1918731
Report NumberMW5019804
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/11/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 03/11/2011 Patient Sequence Number: 1
Treatment
REMERON 15 MG/DAY
CELEXA 40 MG/DAY
KLONOPIN .5 MG/DAY
REMERON 30 MG/DAY
LEXAPRO 20 MG/DAY
KLONOPIN 1 MG/DAY
PILOCARPINE
ALPHAGAN
AZASITE
DOXYCYCLENE
LOTEMAX
HYDROCORTISONE CREAM
LID HYGIENE/SCRUBS
EYE DROP OF ALL SORTS
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