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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX INTRALASE FS SYSTEM

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VISX INTRALASE FS SYSTEM Back to Search Results
Event Type  Injury  
Event Description

Bilateral intralase lasik performed in (b)(6) 2010, using the visx customvue system. Pre surgery prescription od -3. 14 ds -0. 32dc, os -3. 12ds -0. 66dc. Prior to surgery, no dry eye conditions, excellent corrected low light vision, no appearance of floaters, no history of chronic headaches, no history of suicidal thoughts. Three months post surgery complications - pain in the right eye accompanied by headaches, dry eyes, appearance of many dark floaters, starbursts and halos around bright light sources -in both low and moderate lighting conditions-, reduced contrast sensitivity - reduced ability to see well in low lighting-, induced astigmatism. These conditions result in reduced ability to drive at night, reduced ability to concentrate while on the job, reduced ability to participate in activities and everyday tasks in low light settings; increased sensitivity to bright light, increased depression, increased anxiety.

 
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Brand NameVISX
Type of DeviceINTRALASE FS SYSTEM
MDR Report Key1843552
Report NumberMW5017560
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/21/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 09/21/2010 Patient Sequence Number: 1
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