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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES INC CUSTOMVUE CUSTOMVUE VISX

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ABBOTT LABORATORIES INC CUSTOMVUE CUSTOMVUE VISX Back to Search Results
Model Number ABERROMETER: WAVESCAN
Event Type  Injury  
Event Description

I had customvue lasik surgery on (b)(6) 2013 with dr (b)(6) with (b)(6). I experienced normal post surgery results for about 72 hours such as blurred vision, pain, dry eyes. As my daytime vision improved, my night vision did not. My doctor continued to see me, i went to every scheduled f/u visit and i was continuously told i would improve, it was just taking me longer than average. At night outdoors, in low lighting indoors, or when there are different light levels in a room, i cannot see clearly. When night driving, the starbursts combined with halos on all light sources or reflective sources are so large and distorted, they overlap the regular objects i should be seeing, i. E. A car, person walking, front door of a house, curb, road sign etc. Indoors, if there are recessed lights in a ceiling, hanging pendant lights over a kitchen island, chandelier, the lights are overly enlarged that i do not see the objects around the light source. I cannot make our peoples faces in a dimly lit room as the lights overtake the whole area. I cannot see in a restaurant if there are chandeliers, wall sconces or even a candle on the table. All those light sources starbursts are so large they hide everything. When i enter a room that is lit differently from the one i was exiting, my eyes do not adjust like before. It takes many minutes for my eyes to get a minimal amount of focus. Before surgery, i could open a closet door or look into a kitchen cabinet and see what was in there. Now, it is pitch black. My eyes cannot make out any of the objects. I have to use a flashlight to see in a cabinet and the room lights are on. Additionally, during the day, my vision will fluctuate with 1 eye seeing clearly one day and the other eye the next. My right eye continues to see double vision randomly. At night, my left eye starbursts are about double the size of my right eye starbursts. My right eye starbursts already make a light size about 10 times the size of a normal light size. The normal pinpoint indicator light on many electronics that show on/off starburst to about size of volleyball. An average front porch light starbursts to about half the size of the door. The headlights on an average car cover the entire car. These are not the normal halos and glares that are described pre surgery or manageable as a side effect. These are starbursts combined with halos and glares that completely make night vision, low lighting vision and contrast vision inadequate for normal daily function. I have to put drops in my eyes daily at dusk that shrink my pupils to get a few hours of night driving possible. The drops have their own side effects such as heavy eyelids and drowsiness that still make driving difficult. The drops eventually wear off so i have to be sure to be home before that happens. They also take an hour to work, so if i lose track of time and do not realize that it has gotten dark outside, i have to stay put until the drops begin working and i can drive. I also put drops in my eyes every morning and evening for dry eye. My vision after lasik is worse than prior to lasik. I have had no improvement with night vision. I am not experiencing "normal" side effects as advertised. I am a mother of 3 children ages (b)(6) and i own a restaurant and (b)(6). My daily personal life and professional life is completely negatively affected as a result of lasik surgery. I can no longer perform normal daily tasks as i could prior to lasik surgery. I have seen a cornea specialist at wills eye in (b)(6), (b)(6) 2013 and my original ophthalmologist in (b)(6), (b)(6) 2014 with both telling me they don't know what is causing this, however, it obviously is a result of lasik as i did not have these problems before they have told me this is permanent and there is nothing they can recommend to improve this other that daily eyedrops at dusk to shrink my pupils. I have appointments with 2 other eye doctors in the near future to see if they have any suggestions or treatments to improve my vision.

 
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Brand NameCUSTOMVUE
Type of DeviceCUSTOMVUE VISX
Manufacturer (Section D)
ABBOTT LABORATORIES INC
MDR Report Key3600257
Report NumberMW5034080
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberABERROMETER: WAVESCAN
OTHER Device ID NumberSOFTWARE VERSION 5.32

Patient TREATMENT DATA
Date Received: 01/27/2014 Patient Sequence Number: 1
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