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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDITEC LASER EXCIMER, MEDITEC

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MEDITEC LASER EXCIMER, MEDITEC Back to Search Results
Event Date 05/02/1995
Event Type  Injury  
Event Description

I was operated for myopia and astigmatism in 1995 (i had 15 diopters). Since then, i suffer irreversible sequela: halos, glare, flashes, depression with the intent of suicide, reduction on the sensibility to contrast, blurred nocturnal vision and artifical light. I cannot drive at night, i have problems reading or working with the computer, headache, ocular hypertension, cataracts. All this prevented me to have a normal life and work. I would like to know if you know of any solution. Manufactured as oscar blanco lara.

 
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Brand NameLASER EXCIMER, MEDITEC
Type of DeviceLASER EXCIMER, MEDITEC
Manufacturer (Section D)
MEDITEC
MDR Report Key5053545
Report NumberMW5055893
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Report Date 08/07/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2015
Is This An Adverse Event Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/07/2015 Patient Sequence Number: 1
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