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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED MEDICAL OPTICS VISX NONE

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ADVANCED MEDICAL OPTICS VISX NONE Back to Search Results
Model Number STAR S2
Event Date 06/06/2000
Event Type  Injury  
Event Description

I was treated on a visx laser with a 6mm optical zone. My pupils are 8mm. I was not warned that i was a bad candidate. Now i am visually disabled in dim light. At night, i see massive starbursts, halos, and multiple images. Nothing is crisp and clear in dim light-loss of contrast sensitivity. I can't drive at night or participate in any activity in dim light. I had also become contact lens intolerant before lasik which i now know is a sign of dry eyes. My eyes burn constantly and i have recurrent corneal erosions. To say that lasik has negatively affected my quality of life doesn't even begin to cover it. No one, expect other pts who have personally experienced this, can understand what life is like with visual impairment that is not correctable with glasses and non-stop burning dry eyes. I can't tolerate air conditioning, ceiling fans, wind or open a hot oven door. Now my life is all about my eyes and just getting by. The fda should have restricted lasik devices based on pupil size, and placed stronger warnings in the labeling about dry eyes. The fda commissioner said that the fda exists to serve the people, not to serve industries, but it appears to do just the opposite. Dates of use: 2000. Diagnosis or reason for use: moderate myopia. Event abated after use stopped or dose reduced? no.

 
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Brand NameVISX
Type of DeviceNONE
Manufacturer (Section D)
ADVANCED MEDICAL OPTICS
MDR Report Key1047164
Report NumberMW5006928
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/14/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSTAR S2
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No

Patient TREATMENT DATA
Date Received: 05/14/2008 Patient Sequence Number: 1
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