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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUSTOM VUE LASIK CUSTOM VUE LASIK SURGERY

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CUSTOM VUE LASIK CUSTOM VUE LASIK SURGERY Back to Search Results
Event Date 06/22/2005
Event Type  Injury  
Event Description

I underwent custom vue lasik procedure in 2005. After the surgery, i have experienced the following problems in my left eye: approximately 1-2 months after the procedure, my tear ducts left eye completely closed and my left eye is constantly tearing. I have undergone surgery to try to open up the tear ducts, but the surgery was unsuccessful. Over the past 2 years, my vision left eye has been getting progressively worse and i have been diagnosed with ectasia -thinning/warping of the cornea-. Dates of use: 2000 - 2005. Diagnosis or reason for use: correct nearsightedness. Cleaning solution for soft contact lenses.

 
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Brand NameCUSTOM VUE LASIK
Type of DeviceCUSTOM VUE LASIK SURGERY
MDR Report Key1108803
Report NumberMW5007954
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/11/2008
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received08/11/2008
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

Patient TREATMENT DATA
Date Received: 08/11/2008 Patient Sequence Number: 1
Treatment
LOTEMAX
TOBRADEX OINTMENT
DEXAMETHASONE OPHTHALMIC SUSPENSION USP
POLYMYXIN B SULFATES
LIQUID TEARS
TOBRADEX DROPS
NEOMYCIN
ZYMAR
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