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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISXVISXVISX STAR

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VISX VISX VISX STAR   Back to Search Results
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

I had lasik from a dr about 6 years ago. It ruined my vision, and gave me permanent eye pain and dryness. I now see severe halos, ghosts, multiple images, streaks, starbursts, and my vision fluctuates terribly. My contrast sensitivity and depth perception are ruined. It affects my work, my hobbies, every aspect of my life is pain and difficulty. I wake up in the middle of the night from the painful dry eye. I never knew depression until lasik. It's hard for me to believe this horrific lasik procedure is fda approved. These problems are permanent and can't be fixed. I've been to many doctors and none of them can do anything. Dr lied to me about the quality of vision, dryness, side effects, risks, and remedies if something went wrong. He told me that night vision problems were due to older technology and they had been fixed. He told me lasik can't cause permanent dryness. He told me this would be better vision for tennis. He reported that i was "off to a great start" to a referring doctor at a time when i was already experiencing these terrible and permanent problems. I was retreated with ladarvision several months later. The ladarvision didn't fix anything.

 
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Brand NameVISX
Type of DeviceVISX STAR
Manufacturer (Section F)
VISX
Manufacturer (Section D)
VISX
Device Event Key1020244
MDR Report Key1050118
Event Key1008309
Report NumberMW5006996
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 05/21/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2008
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
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

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